drugset / Trial / NCT07109518

uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

NCT07109518 ↗

NaSingle-groupOpen-labelTreatment

Summary

The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.

Timeline

Start
2025-06-28
Primary completion
2028-06-28
Completion
2030-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject uCD7 CART Cell therapy 0.5 cells/kg Intravenous
Subject uCD7 CART Cell therapy 1 cells/kg Intravenous
Subject uCD7 CART Cell therapy 3 cells/kg Intravenous