Actively Recruiting
A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating U32 injection in patients aged 2 to 65 years with acute myeloid leukemia (AML) to assess its safety, tolerability, and effective dosage. This single-arm, open-label clinical study focuses on relapsed and refractory AML according to current diagnostic guidelines, including patients who have undergone prior treatments or stem cell transplants. The study is sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd and spans phases 1 and 2. Participants will receive U32 CAR-T cell therapy following lymphodepletion preconditioning with cyclophosphamide and fludarabine given over three consecutive days. Patients are enrolled into three dose level cohorts to evaluate different dosing regimens. The study does not include a placebo or control group, and all patients receive the investigational treatment. Throughout the study, researchers will monitor adverse events for 28 days post-infusion to assess safety and tolerability. Additional evaluations over two years include pharmacokinetics and pharmacodynamics of the CAR-T cells, response rates, duration of response, overall survival, and progression-free survival. Participants undergo regular follow-ups with clinical assessments to track treatment effects and safety over time.
CONDITIONS
Brief 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 willingness to complete required follow-up
- Aged between 2 and 65 years, any gender
- Diagnosed with relapsed or refractory acute myeloid leukemia per 2022 WHO classification and Chinese guidelines
- Molecularly positive AML patients unresponsive to conventional therapy
- Positive CD38 or CLL-1 expression confirmed by testing
- Previously received at least two lines of treatment or allogeneic hematopoietic stem cell transplantation
- ECOG performance status 0 to 3, expected survival over 3 months
- Adequate bone marrow reserve and blood counts
- Adequate organ function within specified laboratory limits
- For females: non-childbearing or negative pregnancy test and use of contraception as required
- For males: agreement to use contraception or abstinence
- Sufficient venous access and no contraindication for leukapheresis
- At least 3 months washout if previously treated with CD38-targeted therapies
You will not qualify if you...
- Other malignancies within 3 years except certain treated cancers
- Positive for active hepatitis B, hepatitis C, HIV, CMV, EBV, or syphilis infections
- History of severe allergic reactions or allergy to study drug components
- Severe cardiac disease or uncontrolled hypertension
- History or planned solid organ transplant (excluding hematopoietic stem cell transplant)
- Uncontrolled graft-versus-host disease
- Allogeneic hematopoietic stem cell transplant within 6 months
- Active autoimmune, inflammatory, or significant cerebrovascular diseases
- Tumor emergencies requiring urgent treatment
- Active infections requiring antibiotics
- Major surgery planned or wounds not healed
- Severe psychiatric disorders
- Recent systemic corticosteroids or immunosuppressive agents affecting cell preparation
- Recent live virus vaccinations
- History of alcoholism or drug abuse
- Participation in another interventional trial within 30 days
- Any other medical condition posing unacceptable risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepletion preconditioning with cyclophosphamide and fludarabine for 3 consecutive days before receiving U32 CAR-T cell therapy.
3 consecutive daily visits (in-person)
Duration - 1 day
Participants receive a single infusion of U32 CAR-T cells after lymphodepletion preconditioning.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, tolerability, and efficacy outcomes including adverse events and pharmacokinetics for up to 2 years after CAR-T cell infusion.
Visits scheduled periodically over 2 years for assessments
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.
L
Liqing Kang, Ph.D.
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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