Actively Recruiting
uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-03
12
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 70 years
- Diagnosis of relapsed or refractory T-ALL/LBL or AML according to established guidelines
- Tumor cells confirmed positive for CD7
- Bone marrow blast cells 5% or more at screening
- Meet criteria for relapsed or refractory leukemia including primary refractory, relapse within 12 months, multiple relapses, or relapse after transplantation
- Creatinine clearance greater than 60 ml/min
- Serum bilirubin no more than 3 times upper normal limit; ALT and AST no more than 5 times upper normal limit if no liver invasion
- Left ventricular ejection fraction 50% or higher
- Pulse oxygen saturation 92% or higher
- Estimated survival longer than 3 months
- ECOG performance status score between 0 and 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of genetic syndromes causing bone marrow failure (e.g., Fanconi anemia)
- Uncontrolled active central nervous system leukemia
- Recent systemic chemotherapy within 1 week before infusion
- Recent monoclonal antibody therapy within less than 5 half-lives or 4 weeks
- Donor lymphocyte infusion within 6 weeks
- Active uncontrolled serious infections
- Serious heart disease including severe cardiac insufficiency, recent myocardial infarction, unstable angina, prolonged QT interval, or serious arrhythmia
- Recent brain injury or neurological disorders requiring treatment within 6 months
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or high EBV levels
- Need for systemic steroid therapy during CAR-T infusion
- Autoimmune diseases requiring treatment or immunodeficiency
- Recent acute or moderate-to-severe chronic graft-versus-host disease
- Allergy to any component of the cell product
- Pregnant or breastfeeding women and those unable or unwilling to use contraception for one year after infusion
- Any other condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jianxiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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