NCT03590574 · OUTCOME
Duration of TRBC1 Positive T Cell Aplasia.
Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma · Source last updated 2026-03-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Cells/microL
- Interval / dispersion
- Full Range
- Time frame
- Up to 24 months
What was measured
Enumeration of circulating T cell receptor beta constant 1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.
Analysis population: The number analyzed differs from overall number analyzed in some instances because patients died, withdrew of no longer participated in the study for other reasons.
Groups in this outcome
Phase I Dose Escalation - Cohort 1
Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 2
Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 3
Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 4
Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
Total
All patients infused
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 |
|---|
| Phase I Dose Escalation - Cohort 1 | 3 |
|---|
| Phase I Dose Escalation - Cohort 2 | 2 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 15 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 2 |
|---|
| Phase I Dose Escalation - Cohort 2 | 2 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 14 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 28.0 | Not reported | 23 | 33 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 40.0 | Not reported | 12 | 68 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 65.0 | Not reported | 65 | 65 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 3.5 | Not reported | 1 | 843 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 3.0 | Not reported | 3 | 3 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 1.0 | Not reported | 1 | 4 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 316.0 | Not reported | 316 | 316 | Not reported |
|---|
| Total | 8.0 | Not reported | 1 | 843 | Not reported |
|---|
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 2 |
|---|
| Phase I Dose Escalation - Cohort 2 | 2 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 14 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 60.0 | Not reported | 24 | 96 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 98.5 | Not reported | 17 | 180 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 11.0 | Not reported | 11 | 11 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 3.5 | Not reported | 1 | 555 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1.0 | Not reported | 1 | 1 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 7.0 | Not reported | 3 | 28 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 13.0 | Not reported | 13 | 13 | Not reported |
|---|
| Total | 20.0 | Not reported | 3 | 148 | Not reported |
|---|
Day 14
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 2 |
|---|
| Phase I Dose Escalation - Cohort 2 | 2 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 14 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 103.0 | Not reported | 96 | 110 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 84.5 | Not reported | 21 | 148 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 23.0 | Not reported | 23 | 23 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 7.0 | Not reported | 7 | 7 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 14.0 | Not reported | 5 | 22 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 7.0 | Not reported | 3 | 28 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 13.0 | Not reported | 13 | 13 | Not reported |
|---|
| Total | 20.0 | Not reported | 3 | 148 | Not reported |
|---|
Day 28
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 2 |
|---|
| Phase I Dose Escalation - Cohort 2 | 2 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 13 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 78.0 | Not reported | 22 | 134 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 306.0 | Not reported | 291 | 321 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 56.0 | Not reported | 56 | 56 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 18.5 | Not reported | 2 | 134 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 38.0 | Not reported | 38 | 38 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 15.0 | Not reported | 5 | 33 | Not reported |
|---|
| Total | 33.0 | Not reported | 2 | 321 | Not reported |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 1 |
|---|
| Phase I Dose Escalation - Cohort 2 | 1 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 4 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 8 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 193.0 | Not reported | 193 | 193 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 173.0 | Not reported | 173 | 173 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 41.0 | Not reported | 41 | 41 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 26.5 | Not reported | 7 | 82 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.0 | Not reported | 0 | 0 | Not reported |
|---|
| Total | 41.0 | Not reported | 0 | 193 | Not reported |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 0 |
|---|
| Phase I Dose Escalation - Cohort 2 | 1 |
|---|
| Phase I Dose Escalation - Cohort 3 | 1 |
|---|
| Phase I Dose Escalation - Cohort 4 | 1 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 3 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 2 | 29.0 | Not reported | 29 | 29 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 20.0 | Not reported | 20 | 20 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 29.0 | Not reported | 29 | 29 | Not reported |
|---|
| Total | 29 | Not reported | 20 | 29 | Not reported |
|---|
Month 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 0 |
|---|
| Phase I Dose Escalation - Cohort 2 | 0 |
|---|
| Phase I Dose Escalation - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 3 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 20.0 | Not reported | 11 | 32 | Not reported |
|---|
| Total | 20.0 | Not reported | 11 | 32 | Not reported |
|---|
Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 0 |
|---|
| Phase I Dose Escalation - Cohort 2 | 0 |
|---|
| Phase I Dose Escalation - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 3 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 49.0 | Not reported | 8 | 101 | Not reported |
|---|
| Total | 49.0 | Not reported | 8 | 101 | Not reported |
|---|
Month 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 0 |
|---|
| Phase I Dose Escalation - Cohort 2 | 0 |
|---|
| Phase I Dose Escalation - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation - Cohort 4 | 3 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 3 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 38.0 | Not reported | 27 | 177 | Not reported |
|---|
| Total | 38.0 | Not reported | 27 | 177 | Not reported |
|---|
Month 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase I Dose Escalation - Cohort 1 | 0 |
|---|
| Phase I Dose Escalation - Cohort 2 | 1 |
|---|
| Phase I Dose Escalation - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 |
|---|
| Total | 1 |
|---|
Values in Cells/microL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 2 | 61.0 | Not reported | 61 | 61 | Not reported |
|---|
| Total | 61.0 | Not reported | 61 | 61 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 33
- value
- 28.0
- group Id
- OG001
- lower Limit
- 12
- upper Limit
- 68
- value
- 40.0
- group Id
- OG002
- lower Limit
- 65
- upper Limit
- 65
- value
- 65.0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 843
- value
- 3.5
- group Id
- OG004
- lower Limit
- 3
- upper Limit
- 3
- value
- 3.0
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 4
- value
- 1.0
- group Id
- OG006
- lower Limit
- 316
- upper Limit
- 316
- value
- 316.0
- group Id
- OG007
- lower Limit
- 1
- upper Limit
- 843
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24
- upper Limit
- 96
- value
- 60.0
- group Id
- OG001
- lower Limit
- 17
- upper Limit
- 180
- value
- 98.5
- group Id
- OG002
- lower Limit
- 11
- upper Limit
- 11
- value
- 11.0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 555
- value
- 3.5
- group Id
- OG004
- lower Limit
- 1
- upper Limit
- 1
- value
- 1.0
- group Id
- OG005
- lower Limit
- 3
- upper Limit
- 28
- value
- 7.0
- group Id
- OG006
- lower Limit
- 13
- upper Limit
- 13
- value
- 13.0
- group Id
- OG007
- lower Limit
- 3
- upper Limit
- 148
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96
- upper Limit
- 110
- value
- 103.0
- group Id
- OG001
- lower Limit
- 21
- upper Limit
- 148
- value
- 84.5
- group Id
- OG002
- lower Limit
- 23
- upper Limit
- 23
- value
- 23.0
- group Id
- OG003
- lower Limit
- 7
- upper Limit
- 7
- value
- 7.0
- group Id
- OG004
- lower Limit
- 5
- upper Limit
- 22
- value
- 14.0
- group Id
- OG005
- lower Limit
- 3
- upper Limit
- 28
- value
- 7.0
- group Id
- OG006
- lower Limit
- 13
- upper Limit
- 13
- value
- 13.0
- group Id
- OG007
- lower Limit
- 3
- upper Limit
- 148
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Day 14
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22
- upper Limit
- 134
- value
- 78.0
- group Id
- OG001
- lower Limit
- 291
- upper Limit
- 321
- value
- 306.0
- group Id
- OG002
- lower Limit
- 56
- upper Limit
- 56
- value
- 56.0
- group Id
- OG003
- lower Limit
- 2
- upper Limit
- 134
- value
- 18.5
- group Id
- OG004
- lower Limit
- 38
- upper Limit
- 38
- value
- 38.0
- group Id
- OG005
- lower Limit
- 5
- upper Limit
- 33
- value
- 15.0
- group Id
- OG007
- lower Limit
- 2
- upper Limit
- 321
- value
- 33.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 13
- units
- Participants
- title
- Day 28
- categories
- measurements
- group Id
- OG000
- lower Limit
- 193
- upper Limit
- 193
- value
- 193.0
- group Id
- OG001
- lower Limit
- 173
- upper Limit
- 173
- value
- 173.0
- group Id
- OG002
- lower Limit
- 41
- upper Limit
- 41
- value
- 41.0
- group Id
- OG003
- lower Limit
- 7
- upper Limit
- 82
- value
- 26.5
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 0
- value
- 0.0
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 193
- value
- 41.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 8
- units
- Participants
- title
- Month 3
- categories
- measurements
- group Id
- OG001
- lower Limit
- 29
- upper Limit
- 29
- value
- 29.0
- group Id
- OG002
- lower Limit
- 20
- upper Limit
- 20
- value
- 20.0
- group Id
- OG003
- lower Limit
- 29
- upper Limit
- 29
- value
- 29.0
- group Id
- OG007
- lower Limit
- 20
- upper Limit
- 29
- value
- 29
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Month 6
- categories
- measurements
- group Id
- OG003
- lower Limit
- 11
- upper Limit
- 32
- value
- 20.0
- group Id
- OG007
- lower Limit
- 11
- upper Limit
- 32
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Month 9
- categories
- measurements
- group Id
- OG003
- lower Limit
- 8
- upper Limit
- 101
- value
- 49.0
- group Id
- OG007
- lower Limit
- 8
- upper Limit
- 101
- value
- 49.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Month 12
- categories
- measurements
- group Id
- OG003
- lower Limit
- 27
- upper Limit
- 177
- value
- 38.0
- group Id
- OG007
- lower Limit
- 27
- upper Limit
- 177
- value
- 38.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Month 18
- categories
- measurements
- group Id
- OG001
- lower Limit
- 61
- upper Limit
- 61
- value
- 61.0
- group Id
- OG007
- lower Limit
- 61
- upper Limit
- 61
- value
- 61.0
- 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
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- Month 24
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 15
- units
- Participants
- description
- Enumeration of circulating T cell receptor beta constant 1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.
- dispersion Type
- Full Range
- groups
- description
- Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG000
- title
- Phase I Dose Escalation - Cohort 1
- description
- Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG001
- title
- Phase I Dose Escalation - Cohort 2
- description
- Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG002
- title
- Phase I Dose Escalation - Cohort 3
- description
- Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG003
- title
- Phase I Dose Escalation - Cohort 4
- description
- Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG004
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
- description
- Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG005
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
- description
- Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG006
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
- description
- All patients infused
- id
- OG007
- title
- Total
- param Type
- MEDIAN
- population Description
- The number analyzed differs from overall number analyzed in some instances because patients died, withdrew of no longer participated in the study for other reasons.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Duration of TRBC1 Positive T Cell Aplasia.
- type
- SECONDARY
- unit Of Measure
- Cells/microL
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Preserved source evidence · Not medical advice