Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas · Source last updated 2023-01-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
peak percentage
Interval / dispersion
Not reported
Time frame
From time of infusion until 1 month after infusion
What was measured
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR).
Analysis population: Participants #8, and 23 were not assigned to a dose level since they didn't receive chemo or cells. Participant # 5 first enrolled as #3 did not result in cell infusion and was re-enrolled with a new number for cell infusion. This is the same for #18 who was first enrolled as #16.
Groups in this outcome
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
Starting dose: 0.3x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
1.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
3.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m\^2 and 3 participants received 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
9.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.
0.3x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
0.3 x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.
1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
1.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
3
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
3
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
7
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
5
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
3
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Reported measurements
Participant #1 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
2.505994998
Not reported
Not reported
Not reported
Not reported
Participant #2 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1.003513397
Not reported
Not reported
Not reported
Not reported
Participant #4 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.257878064
Not reported
Not reported
Not reported
Not reported
Participant #5 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
5.692026394
Not reported
Not reported
Not reported
Not reported
Participant #6 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.066168665
Not reported
Not reported
Not reported
Not reported
Participant #7 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.875579553
Not reported
Not reported
Not reported
Not reported
Participant #9 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
10.425784436
Not reported
Not reported
Not reported
Not reported
Participant 10 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1.173870125
Not reported
Not reported
Not reported
Not reported
Participant #11 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
25.06555951
Not reported
Not reported
Not reported
Not reported
Participant #12 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
2.061723582
Not reported
Not reported
Not reported
Not reported
Participant #13 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.951813793
Not reported
Not reported
Not reported
Not reported
Participant 14 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
3.770199852
Not reported
Not reported
Not reported
Not reported
Participant #15 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
21.6416809
Not reported
Not reported
Not reported
Not reported
Participant #17 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
9.701843954
Not reported
Not reported
Not reported
Not reported
Participant #18 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
6.193353177
Not reported
Not reported
Not reported
Not reported
Participant #19 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
As pre-specified by the protocol a participant must receive cells to measure percentage and persistence at 1 month. Participant did not receive CAR T cells, so no CAR T cells could possibly be detected in the blood.
Participant #20 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
3.484185735
Not reported
Not reported
Not reported
Not reported
Participant #21 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
51.30355798
Not reported
Not reported
Not reported
Not reported
Participant #22 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
29.40752103
Not reported
Not reported
Not reported
Not reported
Participant #24 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
22.45790377
Not reported
Not reported
Not reported
Not reported
Participant #25 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
55.04760657
Not reported
Not reported
Not reported
Not reported
Participant #26 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
25.56426658
Not reported
Not reported
Not reported
Not reported
Participant #1 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Below the level of detection.
Participant #2 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Below the level of detection.
Participant #4 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Sample not available (participant 4 did not have blood drawn at the 1 month f/u due to not coming to their visit).
Participant #5 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.036582556
Not reported
Not reported
Not reported
Not reported
Participant #6 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.010607229
Not reported
Not reported
Not reported
Not reported
Participant #7 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.002843526
Not reported
Not reported
Not reported
Not reported
Participant #9 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.145937491
Not reported
Not reported
Not reported
Not reported
#10 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.006382466
Not reported
Not reported
Not reported
Not reported
Participant #11 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Sample not available. Participant 11's CAR T cell blood level could not be determined due to technical problems with the research blood sample.
Participant #12 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
2.061723582
Not reported
Not reported
Not reported
Not reported
Participant #13 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Below the level of detection.
Participant #14 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
2.361884069
Not reported
Not reported
Not reported
Not reported
Participant #15 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1.584343701
Not reported
Not reported
Not reported
Not reported
Participant #17 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.09701347
Not reported
Not reported
Not reported
Not reported
Participant #18 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
6.193353177
Not reported
Not reported
Not reported
Not reported
Participants #19 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
As pre-specified by the protocol a participant must receive cells to measure percentage and persistence at 1 month. Participant did not receive CAR T cells, so no CAR T cells could possibly be detected in the blood.
Participant #20 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1.110480727
Not reported
Not reported
Not reported
Not reported
Participant #21 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
8.51303351
Not reported
Not reported
Not reported
Not reported
Participant #22 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
11.65873475
Not reported
Not reported
Not reported
Not reported
Participant #24 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0.289276145
Not reported
Not reported
Not reported
Not reported
Participant #25 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
18.33580648
Not reported
Not reported
Not reported
Not reported
Participant #26 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion
Analysis denominator · Participants
Group
Source count
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
1
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
0
Values in peak percentage · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
NA
Not reported
Not reported
Not reported
Sample not available (participant 26 did not have blood drawn at the 1 month f/u due to not coming to their visit).
Complete source fields
classes
categories
measurements
group Id
OG000
value
2.505994998
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #1 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG000
value
1.003513397
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #2 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG000
value
0.257878064
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #4 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG001
value
5.692026394
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #5 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG001
value
0.066168665
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #6 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG001
value
0.875579553
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #7 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG004
value
10.425784436
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
units
Participants
title
Participant #9 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG004
value
1.173870125
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
units
Participants
title
Participant 10 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG002
value
25.06555951
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #11 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG002
value
2.061723582
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #12 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG002
value
0.951813793
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant #13 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
categories
measurements
group Id
OG002
value
3.770199852
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants
title
Participant 14 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
5
group Id
OG004
value
3
group Id
OG005
value
1
units
Participants
description
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR).
groups
description
Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
Starting dose: 0.3x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
OG000
title
Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
description
Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
1.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
OG001
title
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
description
Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
3.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m\^2 and 3 participants received 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
OG002
title
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
description
Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
9.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
OG003
title
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
description
Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.
0.3x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
0.3 x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
OG004
title
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
description
Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.
1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight
1.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
OG005
title
Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg
param Type
NUMBER
population Description
Participants #8, and 23 were not assigned to a dose level since they didn't receive chemo or cells. Participant # 5 first enrolled as #3 did not result in cell infusion and was re-enrolled with a new number for cell infusion. This is the same for #18 who was first enrolled as #16.
reporting Status
POSTED
time Frame
From time of infusion until 1 month after infusion
title
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Triangle