Relapsed or Refractory Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)
This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be
enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose
expansion trial).Subjects will be divided into low-dose group, medium-dose group and
high-dose group.Additional patients will be enrolled to confirm the optimal dose
Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
Phase 2 |