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Clinical Trial Summary

- 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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06027957
Study type Interventional
Source Vinmec Research Institute of Stem Cell and Gene Technology
Contact Thanh Liem Nguyen, PhD
Phone +84 4 3974 3556
Email v.liemnt@vinmec.com
Status Recruiting
Phase Phase 1
Start date August 2, 2023
Completion date July 31, 2025

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