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

NCT06027957 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Hematology and Blood Transfusion, Vietnam

    collaborator OTHER

  • Vinmec Research Institute of Stem Cell and Gene Technology

    lead OTHER

Principal Investigators

  • Thanh Liem Nguyen, PhD · Vinmec Research Institute of Stem Cell and Gene Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027957 on ClinicalTrials.gov