NCT03590574 · OUTCOME
To Determine the Expansion and Persistence of AUTO4 Following Infusion.
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
- copies/microgram DNA
- Interval / dispersion
- Full Range
- Time frame
- Up to 24 months
What was measured
RQR8/aTRBC1-CAR positive T cells as determined by polymerase chain reaction 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 or no longer participated in the study for other reasons. Zero values indicate that assessments were performed but no RQR8/aTRBC1-CAR positive T cells were detected by polymerase chain reaction.
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
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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 52.25 | Not reported | 0.0 | 1039.3 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 904.20 | Not reported | 422.4 | 3974.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 3951.70 | Not reported | 3951.7 | 3951.7 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 3951.7 | Not reported |
|---|
Day 9
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 | 2 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 14 |
|---|
Values in copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 147.20 | Not reported | 147.2 | 147.2 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 147.2 | Not reported |
|---|
Day 12
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 | 2 |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
|---|
| Total | 13 |
|---|
Values in copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 147.30 | Not reported | 147.3 | 147.3 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 147.3 | Not reported |
|---|
Day 15
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 |
|---|
Values in copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 114.20 | Not reported | 114.2 | 114.2 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 114.2 | Not reported |
|---|
Day 28
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 | 0 |
|---|
| 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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 1 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 | 2 |
|---|
| 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 | 5 |
|---|
Values in copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 3 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 | 2 |
|---|
| 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 | 2 |
|---|
Values in copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | 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 | 2 |
|---|
| 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 copies/microgram DNA · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase I Dose Escalation - Cohort 2 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Phase I Dose Escalation - Cohort 4 | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Total | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 1039.3
- value
- 52.25
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG005
- lower Limit
- 422.4
- upper Limit
- 3974.0
- value
- 904.20
- group Id
- OG006
- lower Limit
- 3951.7
- upper Limit
- 3951.7
- value
- 3951.70
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 3951.7
- value
- 0.00
- 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
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG004
- lower Limit
- 147.2
- upper Limit
- 147.2
- value
- 147.20
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 147.2
- value
- 0.00
- 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
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Day 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG004
- lower Limit
- 147.3
- upper Limit
- 147.3
- value
- 147.30
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 147.3
- value
- 0.00
- 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
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 13
- units
- Participants
- title
- Day 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG004
- lower Limit
- 114.2
- upper Limit
- 114.2
- value
- 114.20
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 114.2
- value
- 0.00
- 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
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- 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
- 0
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Day 28
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- 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
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- units
- Participants
- title
- Month 6
- categories
- measurements
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- 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
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- units
- Participants
- title
- Month 12
- categories
- measurements
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- 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
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- 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
- RQR8/aTRBC1-CAR positive T cells as determined by polymerase chain reaction 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 or no longer participated in the study for other reasons. Zero values indicate that assessments were performed but no RQR8/aTRBC1-CAR positive T cells were detected by polymerase chain reaction.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- To Determine the Expansion and Persistence of AUTO4 Following Infusion.
- type
- SECONDARY
- unit Of Measure
- copies/microgram DNA
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle