TriangleNCT02028455 · OUTCOME
Persistence of Functional CD19 CAR+ T Cells
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
- Initial CAR T Infusion through Day 63 post infusion assessment (+/- 14 days)
What was measured
Participants will be followed for 63 days to determine if the transferred T cells remain detectable in the blood and bone marrow
Analysis population: Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in Cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide and who were followed for loss of persistence through the Day 63 assessment window. Excludes one participant with insufficient samples collected to determine Day 63 persistence status.
Groups in this outcome
SCRI-CAR19v1/v1.5 Efficacy- and Persistence-evaluable Leukemia Cohort
Participants from the efficacy-evaluable leukemia population who were followed for loss of persistence through the d63 assessment window.
| Group | Source count |
|---|---|
| SCRI-CAR19v1/v1.5 Efficacy- and Persistence-evaluable Leukemia Cohort | 70 |
Reported measurements
Source class 1
Number of participants with functional CAR T cell persistence through the Day 63 study assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SCRI-CAR19v1/v1.5 Efficacy- and Persistence-evaluable Leukemia Cohort | 42 | Not reported | Not reported | Not reported | Not reported |
Number of participants without functional CAR T cell persistence through the Day 63 study assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SCRI-CAR19v1/v1.5 Efficacy- and Persistence-evaluable Leukemia Cohort | 28 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 42
- title
- Number of participants with functional CAR T cell persistence through the Day 63 study assessment
- measurements
- group Id
- OG000
- value
- 28
- title
- Number of participants without functional CAR T cell persistence through the Day 63 study assessment
- denoms
- counts
- group Id
- OG000
- value
- 70
- units
- Participants
- description
- Participants will be followed for 63 days to determine if the transferred T cells remain detectable in the blood and bone marrow
- groups
- description
- Participants from the efficacy-evaluable leukemia population who were followed for loss of persistence through the d63 assessment window.
- id
- OG000
- title
- SCRI-CAR19v1/v1.5 Efficacy- and Persistence-evaluable Leukemia Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in Cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide and who were followed for loss of persistence through the Day 63 assessment window. Excludes one participant with insufficient samples collected to determine Day 63 persistence status.
- reporting Status
- POSTED
- time Frame
- Initial CAR T Infusion through Day 63 post infusion assessment (+/- 14 days)
- title
- Persistence of Functional CD19 CAR+ T Cells
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice