Actively Recruiting
Clinical Study of U32 in Patients With Acute Myeloid Leukemia
Led by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Updated on 2025-06-25
20
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.
CONDITIONS
Official Title
Clinical Study of U32 in Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and expected to complete follow-up examinations and treatments
- Aged 2 to 65 years, any gender
- Diagnosed with relapsed or refractory acute myeloid leukemia per 2022 WHO classification and Chinese guidelines
- Molecularly positive AML patients not achieving negativity through conventional therapy
- Positive expression of CD38 or CLL-1 by immunohistochemistry or flow cytometry
- Previously received at least two adequate treatment lines or allogeneic hematopoietic stem cell transplantation
- ECOG performance status 0 to 3 with expected survival over 3 months
- Adequate bone marrow reserve: absolute lymphocyte count ≥0.3×10^9/L, platelets ≥20×10^9/L (including with transfusion)
- Appropriate organ function: AST ≤3×ULN, ALT ≤3×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min, hemoglobin ≥60 g/L or maintained after transfusion, oxygen saturation ≥92%, LVEF ≥45%
- Female subjects must be non-childbearing or have negative pregnancy test and agree to contraception during and 1 year after study
- Male subjects of childbearing potential must use barrier contraception or abstain until 1 year after study
- Sufficient venous access for apheresis or blood draw and no leukapheresis contraindications
- At least 3 months washout after daratumumab or other CD38-targeted therapies before reinfusion
You will not qualify if you...
- Other malignancies within 3 years except certain treated cancers (e.g., cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma of skin)
- Positive for hepatitis B surface antigen or core antibody with detectable HBV-DNA, hepatitis C antibodies with detectable HCV-RNA, HIV antibodies, CMV DNA, EBV-DNA, or syphilis serology
- History of severe allergic reactions or known allergy to study drug components or lymphodepletion regimen
- Severe cardiac disease including severe arrhythmias, unstable angina, large myocardial infarction, NYHA Class III or IV heart failure, or refractory hypertension
- History of solid organ transplant or planned transplant (excluding hematopoietic stem cell transplant)
- Uncontrollable acute or chronic graft-versus-host disease
- Allogeneic hematopoietic stem cell transplant within 6 months prior to screening
- Active autoimmune or inflammatory diseases or significant cerebrovascular disease
- Tumor emergencies requiring urgent treatment prior to screening
- Uncontrollable infections requiring antibiotic therapy
- Planned major surgery within 4 weeks prior to lymphodepletion or during study or unhealed surgical wounds
- Severe psychiatric disorders
- Systemic corticosteroid or immunosuppressive agent use within 1 week prior to PBMC collection affecting cell preparation
- Live-attenuated or live virus vaccines within 4 weeks prior to screening
- History of alcoholism or drug abuse
- Participation in another interventional clinical trial within 30 days prior to screening
- Any medical condition posing unacceptable risk or contraindicating study procedures per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University, Suzhou, JiangSu 215000 Recruiting
Suzhou, China, 215000
Actively Recruiting
Research Team
X
Xiaowen Tang, Ph.D.
CONTACT
L
Liqing Kang, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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