TriangleNCT03590574 · OUTCOME
Frequency and Severity of All Adverse Events (AEs) and Serious Adverse Events (SAEs).
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
All AEs/SAEs were recorded from admission for pre-conditioning chemotherapy (Day -6 relative to AUTO4). Due to the long period between consent and AUTO4 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
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
Patients Leukapheresed But Not Treated
Patients who underwent leukapheresis procedure but discontinued before AUTO4 infusion
| 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 |
| Patients Leukapheresed But Not Treated | 5 |
Reported measurements
Patients with any AE
| 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 | 2 | 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 |
| Total | 14 | Not reported | Not reported | Not reported | Not reported |
| Patients Leukapheresed But Not Treated | 1 | Not reported | Not reported | Not reported | Not reported |
Patients with any AE of Grade 3 or higher
| 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 | 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 |
| Total | 13 | Not reported | Not reported | Not reported | Not reported |
| Patients Leukapheresed But Not Treated | 1 | Not reported | Not reported | Not reported | Not reported |
Patients with any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Escalation - Cohort 1 | 2 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 4 | 2 | 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 | 2 | 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 |
| Total | 8 | Not reported | Not reported | Not reported | Not reported |
| Patients Leukapheresed But Not Treated | 1 | Not reported | Not reported | Not reported | Not reported |
Patients with any SAE of Grade 3 or higher
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Escalation - Cohort 1 | 2 | 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 | 1 | 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 |
| Total | 5 | Not reported | Not reported | Not reported | Not reported |
| Patients Leukapheresed But Not Treated | 1 | 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
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 1
- title
- Patients with any AE
- 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
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 13
- group Id
- OG008
- value
- 1
- title
- Patients with any AE of Grade 3 or higher
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 1
- title
- Patients with any SAE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 1
- title
- Patients with any SAE of Grade 3 or higher
- 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
- group Id
- OG008
- value
- 5
- units
- Participants
- description
- All AEs/SAEs were recorded from admission for pre-conditioning chemotherapy (Day -6 relative to AUTO4). Due to the long period between consent and AUTO4 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
- 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
- description
- Patients who underwent leukapheresis procedure but discontinued before AUTO4 infusion
- id
- OG008
- title
- Patients Leukapheresed But Not Treated
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 24 months post treatment
- title
- Frequency and Severity of All Adverse Events (AEs) and Serious Adverse Events (SAEs).
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice