NCT03049449 · OUTCOME

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively.

What was measured

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

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. 1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight 1.0 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 - 3.0x10^6 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. 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: 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 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	1

Reported measurements

Source class 1

Values in Participants · 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	3	Not reported	Not reported	Not reported	Not reported
Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	3	Not reported	Not reported	Not reported	Not reported
Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	7	Not reported	Not reported	Not reported	Not reported
Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	5	Not reported	Not reported	Not reported	Not reported
Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	3	Not reported	Not reported	Not reported	Not reported
Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
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

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

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. 1.0x10\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight 1.0 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. 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: 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 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively.

title

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

type

OTHER_PRE_SPECIFIED

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice