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drugset / Trial / NCT03754764

A Feasibility and Safety Study of CD38 CAR-T Cell Immunotherapy for Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T Adoptive Cellular Immunotherapy

NCT03754764 ↗

Phase 1/2 Unknown 80 enrolled Chinese PLA General Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. CD38 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD38. This is a phase 1/2 study designed to determine the safety of the gene-edited specificity CD38 CAR-T cells and the feasibility of making enough to treat patients with relapsed B-cell acute lymphoblastic leukemia after CD19 CAR-T adoptive cellular immunotherapy.

Timeline

Start
2018-11-23
Primary completion
2022-11-23
Completion
2022-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Specificity CD38 CAR-T Cells Cell therapy 1e+06 cells/kg Intravenous
Subject Specificity CD38 CAR-T Cells Cell therapy 5e+06 cells/kg Intravenous

Indications

B-cell acute lymphoblastic leukemia