Actively Recruiting
SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-15
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 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.
CONDITIONS
Official Title
SupCD7 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, any gender
- Diagnosed with relapsed or refractory T-ALL/LBL according to NCCN guidelines
- Diagnosed with acute myeloid leukemia (AML) per official guidelines
- Tumor cells confirmed CD7 positive by cytology
- Bone marrow blast count of 5% or higher at screening
- Meet criteria for relapsed/refractory AML including primary refractory, early relapse, multiple relapses, or post-transplant relapse
- Meet criteria for relapsed/refractory T-ALL/LBL including primary refractory, relapse within 12 months, or post-transplant or post-CAR-T relapse
- Diagnosed with other relapsed/refractory CD7 positive hematologic malignancies
- Creatinine clearance greater than 60 ml/min
- Serum total bilirubin no more than 3 times the upper normal limit
- Serum ALT and AST no more than 5 times the upper normal limit if no liver invasion
- Left ventricular ejection fraction (LVEF) at least 50%
- Pulse oxygen saturation 92% or higher
- Estimated survival time greater than 3 months
- Performance status score of 0 to 2
- Willingness and ability to voluntarily participate and sign 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's anemia, Kostmann's syndrome)
- Uncontrolled active central nervous system leukemia (CNSL) with cerebrospinal fluid grade CNS 2 or CNS 3
- Recent anti-tumor therapy: systemic chemotherapy within 1 week, monoclonal antibody infusion within 5 half-lives or 4 weeks, donor lymphocyte infusion within 6 weeks
- Uncontrolled serious active infections at screening
- History of serious heart disease including severe cardiac insufficiency, recent myocardial infarction, unstable angina, significant ECG abnormalities
- Recent serious neurological conditions requiring treatment within 6 months
- Active infections with hepatitis B, hepatitis C, HIV, syphilis, or active Epstein-Barr virus infection
- Requirement for systemic steroid therapy during CAR-T infusion, except for inhaled or local steroids
- Autoimmune diseases requiring treatment or immunodeficiency requiring immunosuppressive therapy
- Acute graft-versus-host disease or moderate-to-severe chronic graft-versus-host disease within 4 weeks
- History of allergy to any component of the cell therapy product
- Pregnant or breastfeeding females; males or females of childbearing potential unable to use effective contraception for 1 year after infusion
- Any condition that may increase risk or interfere with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here