Relapsed or Refractory Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia. Primary objectives: Determine the safety and tolerability of ssCART-19 cells in patients with refractory or relapsed acute lymphoblastic leukemia. Secondary objectives: 1. Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. - Overall remission rate (ORR) assessment during the 3 months after ssCART-19 administration，ORR includes CR and CRi - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) 2. To characterize the in vivo cellular pharmacokinetic (PK) profile of ssCART-19 cells. 3. To characterize the pharmacodynamic (PD) profile of ssCART-19 cells. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04230473 -
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
|
Phase 1 | |
| Terminated |
NCT01887587 -
Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia
|
Phase 1 | |
| Recruiting |
NCT03018093 -
A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL
|
Phase 1 | |
| Recruiting |
NCT04684147 -
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Not yet recruiting |
NCT06367114 -
Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)
|
Phase 2 |