Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03952923 | CD19-CAR-T in B-cell Malignancies Patients | PHASE1 | COMPLETED | 11 | — | — | Aug 1, 2019 | Mar 31, 2021 | Feb 1, 2022 | 1 | China |
Percentage of participants with adverse events.
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
| Arm | Type | Description |
|---|---|---|
| CD19-CAR-T cells | EXPERIMENTAL | CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion. |
| Name | Type | Description |
|---|---|---|
| CD19-CAR-T cells | BIOLOGICAL | CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion. |
Inclusion Criteria: 1. Relapsed and refractory CD19 positive B-cell acute malignancies with: * Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%); * MRD≥0.1% after allogeneic hematopoietic stem cell transplanta...