TriangleNCT03590574 · OUTCOME
To Assess the Overall Safety and Tolerability of AUTO4.
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
- 24 months post treatment
What was measured
Incidence and severity of opportunistic infections following AUTO4 infusion.
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
| 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 |
Reported measurements
Any infection or infestation post-infusion
| 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 | 1 | 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 | 1 | 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 | 1 | 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 |
Any infection or infestation of Grade 3 or higher post-infusion
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Escalation - Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 1 | 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 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- title
- Any infection or infestation post-infusion
- categories
- measurements
- 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
- 1
- group Id
- OG006
- value
- 1
- title
- Any infection or infestation of Grade 3 or higher post-infusion
- 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
- units
- Participants
- description
- Incidence and severity of opportunistic infections following AUTO4 infusion.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 24 months post treatment
- title
- To Assess the Overall Safety and Tolerability of AUTO4.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice