B-Cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
- Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR). - Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. - Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. - Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
Objectives: - Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy. - Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria: - Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion - Progression-free survival (PFS) after infusion of CD19 CAR T-cells - Event-free survival (EFS) after infusion of CD19 CAR T-cells - Overall survival (OS) after infusion of CD19 CAR T-cells ;
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