This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E51E62E63E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored. The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral bloodPB and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
| Condition | Refractory and Relapsed B Cell Acute Leukemia |
|---|---|
| Treatment | CD19/CD22-Dual-STAR-T |
| Clinical Study Identifier | NCT04508842 |
| Sponsor | Hebei Yanda Ludaopei Hospital |
| Last Modified on | 5 March 2022 |
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