Relapsed B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase II Clinical Study of CAR-T-19 (Anti-CD19 Single-chain Antibody Chimeric Antigen Receptor T Cell) Injection in the Treatment of CD19-positive Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (Inclusive)
This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 1.5 x10^6 cells/kg（range 0.5-1.5×10^6 cells/kg）. ;
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