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RECRUITING
NCT07153068
PHASE1/PHASE2

SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

The aim of this study was to evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase Ⅰ+Ⅱ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the MTD of each cohort using a 3+3 dose escalation and rapid titration design.

Official title: Super-universal CD7 CART (supCD7 CART) Cell Injection in the Treatment of Relapsed or Refractory CD7 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-06-28

Completion Date

2030-06-28

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

supCD7 CART cells

Subjects screened to meet the requirements for supCD7 CART cells use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of supCD7 CART cells must be performed 24 hours after completion of chemotherapy preconditioning. supCD7 CART cells can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China