RecruitingPhase 1Phase 2NCT07153068

SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

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.


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 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized CAR-T cell therapy (engineered immune cells) for people with relapsed or treatment-resistant blood cancers that carry a marker called CD7. The cancers targeted include certain types of leukemia (T-ALL, AML) and other CD7-positive blood cancers. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with relapsed or refractory T-ALL, AML, or another CD7-positive blood cancer - Your cancer cells are confirmed CD7-positive - You have at least 5% blast cells in the bone marrow - Your heart, kidneys, and liver function are within acceptable ranges - Your cancer has not responded to at least 2 rounds of standard chemotherapy, or has relapsed **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific subtype) - You have an uncontrolled active central nervous system leukemia - You have a serious heart condition, recent heart attack, or severe arrhythmia - You have active uncontrolled infections - You are pregnant or breastfeeding - You have had prior allergy to cell therapy products - You have certain viral infections (hepatitis B/C, HIV, syphilis) - You have had uncontrolled graft-versus-host disease in the past month 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

BIOLOGICALsupCD7 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

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NCT07153068


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