NCT06027957

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• B-Cell Non Hodgkin Lymphoma
• B-Cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 CAR T-cells	For Biological: CD19 CAR T-cells * Dose: 1-2.10e6 cells/kg of weight * Route: intravenous infusion For Chemotherapy Drug: * Fludarabine (30 mg/m2/day) given intravenously (IV) on day -5 to -3. * Cyclophosphamide 500 mg/m2/day for NHL and 250 mg/m2/day for ALL given IV from day -5 to -3. * Mesna 500 mg/m2/day for NHL and 250 mg/m2/day for ALL, divided in three infusions: one day before the cyclophosphamide infusion, and 4 and 8 hours after.

Timeline

• Start date: 2023-08-02
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2023-09-07
• Last updated: 2025-08-26

Locations

1 site across 1 country: Vietnam