drugset / Trial / NCT04264078

Summary

The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19 CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical experiments is cheerful.however, how to select the functional T cells from the malignant T cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-CD7 universal CAR-T cells could be accessible and affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies.

Timeline

Start
2021-03-01
Primary completion
2022-06-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CD7 UCAR-T cells Cell therapy 1e+07 cells/kg
Subject CD7 UCAR-T cells Cell therapy 3e+07 cells/kg
Subject CD7 UCAR-T cells Cell therapy 5e+07 cells/kg
Background Cyclophosphamide Other / unclassified 600 mg/m2
Background Fludarabine Small molecule 30 mg/m2
Background Melphalan Small molecule 50 mg/m2
Background Melphalan Small molecule 70 mg/m2