drugset
drugset / Trial / NCT06027957

CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia

NCT06027957 ↗

Phase 1 Completed 18 enrolled Vinmec Research Institute of Stem Cell and Gene Technology National Institute of Hematology and Blood Transfusion, Vietnam · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-02
Primary completion
2025-06-30
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-CD19 CAR-T cells Cell therapy 1e+06 cells/kg Intravenous
Subject anti-CD19 CAR-T cells Cell therapy 2.1e+06 cells/kg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 250 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 500 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 250 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

B-cell acute lymphoblastic leukemia