Actively Recruiting
Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-04-03
15
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.
CONDITIONS
Official Title
Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma
- For T-ALL: Bone marrow with 6% blasts or MRD positive and refractory or relapsed after standard treatments
- For T-cell lymphoma: At least one measurable lesion and refractory or relapsed after two or more chemotherapy lines or post stem cell transplant
- CD5 positivity confirmed by flow cytometry or immunohistochemistry
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ function including heart, kidney, liver, and lungs
- No contraindications to leukapheresis or cell collection
- No severe psychiatric disorders
- Agreement to use effective contraception from consent until 1 year after therapy for patients who can bear children
- Signed informed consent confirming understanding of the trial
You will not qualify if you...
- Prior treatment with CAR-NK or genetically modified cell therapy
- Active central nervous system involvement at screening
- Recent chemotherapy, targeted therapy, investigational drugs within 2 weeks or 5 half-lives before screening
- Radiotherapy within 2 weeks before screening
- Active or uncontrolled infection within 1 week before screening
- Stroke, seizure, or similar event within 6 months before screening
- Active viral infections including HBV, HCV, HIV, syphilis, or tuberculosis
- Severe heart conditions including NYHA Class III/IV heart failure, recent heart attack, significant arrhythmia, or severe cardiomyopathy
- Active or uncontrolled autoimmune disease
- Other cancers within 5 years except certain cured types
- Live vaccine within 4 weeks before screening
- Pregnancy, breastfeeding, or planning pregnancy within 1 year after therapy
- Any other condition deemed by the investigator to cause ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
J
Jia Wei, MD
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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