Actively Recruiting
U96-CAR-T-Cells For R/R B-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-06
30
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label clinical investigation to evaluate the tolerance, safety and preliminary efficacy of CAR-T (U96) in the treatment of relapsed/refractory B-cell tumors. The study will be conducted in two disease types, acute B-lymphoblastic leukemia and B-cell lymphoma, with a dose escalation plan using the "3+3" method. Each dose group is planned to enroll 3 to 6 patients, with a total of approximately 30 to 48 patients to be enrolled in the entire study. After signing the informed consent form, patients will undergo screening tests. If they meet the inclusion and exclusion criteria, they will be enrolled in the study. After receiving U96 treatment, patients will be followed up. It is recommended that they stay in the hospital for at least 14 days after administration. Safety and efficacy follow-ups will be conducted at 28 days and 3, 6, 12, 18, and 24 months after treatment. The follow-up period after treatment will last for 2 years, with a long-term follow-up of 15 years to assess the efficacy and safety until the end of the study or the patient withdraws from the study. For patients who have received U96 treatment, even if they withdraw from the study early, the investigators should still conduct long-term safety follow-ups according to the protocol to evaluate the long-term safety of the product.
CONDITIONS
Official Title
U96-CAR-T-Cells For R/R B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign the informed consent form and have good compliance
- Age 18 years or older, any gender
- Diagnosed with acute B lymphoblastic leukemia or B-cell lymphoma according to NCCN guidelines
- For acute B lymphoblastic leukemia: refractory or relapsed disease as defined by guideline criteria
- For B-cell lymphoma: failed at least two lines of treatment including CD20 monoclonal antibody and anthracycline-based regimen, or relapsed before screening
- Bone marrow, blood, or pathology shows CD19 antigen positive
- At least one evaluable lesion per Lugano Lymphoma Response Criteria or positive PET-CT lesion (for lymphoma patients)
- ECOG performance status score between 0 and 3
- Bone marrow reserve with absolute lymphocyte count ≥ 0.3×10⁹/L and platelet count ≥ 30×10⁹/L (including post-treatment results)
- Adequate organ function including liver, kidney, lung, and heart parameters within specified limits
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study and for 1 year after treatment
- Expected survival longer than 3 months
You will not qualify if you...
- Having another malignant tumor that may affect current treatment
- Positive for hepatitis B surface antigen or core antibody with detectable HBV-DNA, positive for hepatitis C antibody with detectable HCV-RNA, positive for anti-mycoplasma antibody, or positive for HIV antibody
- Active bacterial, fungal, viral, mycoplasma, or other infections judged difficult to control
- History or presence of uncontrolled central nervous system diseases such as epilepsy, stroke, dementia, or CNS autoimmune diseases
- Cardiac angioplasty or stent placement within 12 months before consent, NYHA class III-IV heart failure, myocardial infarction, unstable angina, significant heart disease history, QTc interval > 480 ms, or left ventricular ejection fraction < 50%
- Primary immunodeficiency
- Severe immediate hypersensitivity to any study drug
- Received live vaccines within 6 weeks before screening
- Pregnant or lactating women
- Active autoimmune diseases
- Active acute or chronic graft-versus-host disease judged uncontrollable
- Participation in other interventional clinical trials within 30 days before consent
- Any condition deemed unsuitable for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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