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 6E5、1E6、2E6、3E6 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 blood(PB), and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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 CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China
Percentage of participants with adverse events.
Percentage of participants with adverse events.
Time frame: 12 months
Objective Remission Rate(ORR)
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
Time frame: 12 months
Proliferation ratio of Dual-STAR-T cells
Time frame: 12 months
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