TriangleNCT02028455 · OUTCOME
Number of Participants Who Have a Releasable Cell Product Generated
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 28 days per manufacturing attempt
What was measured
The feasibility of manufacturing and releasing T cell products from pediatric and young adult patients with CD19+ relapsed or refractory leukemia
Analysis population: Participants evaluable for manufacturing feasibility.
Groups in this outcome
Phase 1-Cohort 1A
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Not Treated
This phase 1 cohort did not receive Patient Derived CD19 specific CAR T cells
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
| Group | Source count |
|---|---|
| Phase 1-Cohort 1A | 7 |
| Phase 1-Cohort 1B | 12 |
| Phase 1-Cohort 1C | 7 |
| Phase 1-Cohort 1D | 5 |
| Phase 1-Cohort 1F1 | 6 |
| Phase 1-Cohort 1F2 | 6 |
| Phase 1 - Not Treated | 3 |
| Phase 2 | 119 |
Reported measurements
Source class 1
Number of participants for whom a releasable CAR T cell product was manufactured
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1-Cohort 1A | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1B | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1C | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1D | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1F1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1F2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 - Not Treated | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 116 | Not reported | Not reported | Not reported | Not reported |
Number of participants for whom no releasable CAR T cell product was manufactured
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1-Cohort 1A | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1B | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1C | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1D | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1F1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1-Cohort 1F2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 - Not Treated | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 116
- title
- Number of participants for whom a releasable CAR T cell product was manufactured
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- title
- Number of participants for whom no releasable CAR T cell product was manufactured
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 119
- units
- Participants
- description
- The feasibility of manufacturing and releasing T cell products from pediatric and young adult patients with CD19+ relapsed or refractory leukemia
- groups
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
- id
- OG000
- title
- Phase 1-Cohort 1A
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
- id
- OG001
- title
- Phase 1-Cohort 1B
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
- id
- OG002
- title
- Phase 1-Cohort 1C
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
- id
- OG003
- title
- Phase 1-Cohort 1D
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
- id
- OG004
- title
- Phase 1-Cohort 1F1
- description
- This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
- id
- OG005
- title
- Phase 1-Cohort 1F2
- description
- This phase 1 cohort did not receive Patient Derived CD19 specific CAR T cells
- id
- OG006
- title
- Phase 1 - Not Treated
- description
- The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
- id
- OG007
- title
- Phase 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants evaluable for manufacturing feasibility.
- reporting Status
- POSTED
- time Frame
- Up to 28 days per manufacturing attempt
- title
- Number of Participants Who Have a Releasable Cell Product Generated
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice