drugset / Trial / NCT03398967

A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma

NCT03398967 ↗

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. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.

Timeline

Start
2018-01-02
Primary completion
2022-05-20
Completion
2022-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells Cell therapy — Intravenous