TriangleNCT03590574 · OUTCOME
Determine the Complete Response (CR) Rate Following Treatment With 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
- Up to 24 months
What was measured
Participants achieving CR per Lugano criteria based on independent central radiology review. The Lugano classification of response by 18F (Fluorine isotope 18)-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography (CT): 1. no uptake or no residual uptake (when used interim) 2. slight uptake, but below blood pool (mediastinum) 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion
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 | 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
Source class 1
| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation - Cohort 4 | 3 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Total | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- 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
- Participants achieving CR per Lugano criteria based on independent central radiology review. The Lugano classification of response by 18F (Fluorine isotope 18)-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography (CT): 1. no uptake or no residual uptake (when used interim) 2. slight uptake, but below blood pool (mediastinum) 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion
- 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Determine the Complete Response (CR) Rate Following Treatment With AUTO4.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice