RecruitingPhase 1NCT07109518

uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

Universal CD7 CART (uCD7 CART) Cell Injection in the Treatment of Relapsed or Refractory CD7 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

12 participants

Start Date

Jun 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing uCD7 CAR-T cell therapy — a treatment where a patient's immune cells are engineered to find and destroy cancer cells carrying the CD7 protein — for people with relapsed or refractory CD7-positive blood cancers, including T-cell leukemia, T-cell lymphoma, and certain types of acute myeloid leukemia. **You may be eligible if:** - You are between 18 and 70 years old - You have been diagnosed with T-cell acute lymphoblastic leukemia/lymphoma or acute myeloid leukemia - Your cancer cells test positive for the CD7 protein - At least 5% of your bone marrow cells are cancer blasts - Your cancer has relapsed or has not responded to prior treatment **You may NOT be eligible if:** - Your cancer cells do not express CD7 - You have not had prior treatment (this is for relapsed/refractory cases) - You have serious organ problems that make CAR-T therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALuCD7 CART

Subjects screened to meet the requirements for uCD7 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine (Flu) and cyclophosphamide (CTX) based preconditioning should be performed within 1 week prior to uCD7 CART infusion: Flu 30mg/m2 ×3 days; 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 etoposide. Infusion of uCD7 CART must be performed 24 hours after completion of chemotherapy preconditioning. uCD7 CART 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

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NCT07109518


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