TriangleNCT03590574 · OUTCOME
Feasibility of Generating AUTO4: Number of Patients Whose Cells Achieve Successful AUTO4 Manufacture as a Proportion of the Number of Patients Undergoing Leukapheresis.
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
- Up to 8 weeks post leukapheresis
What was measured
Feasibility of product generation was examined by assessing the number of AUTO4 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
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 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
Not Treated
Did not receive therapeutic product
| 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 |
| Not Treated | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Escalation - Cohort 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 4 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Not Treated | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 0
- 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
- 5
- units
- Participants
- description
- Feasibility of product generation was examined by assessing the number of AUTO4 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
- 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 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
- Did not receive therapeutic product
- id
- OG007
- title
- Not Treated
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 8 weeks post leukapheresis
- title
- Feasibility of Generating AUTO4: Number of Patients Whose Cells Achieve Successful AUTO4 Manufacture as a Proportion of the Number of Patients Undergoing Leukapheresis.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice