U96-CAR-T-Cells For R/R B-ALL (NCT07511426) | Clinical Trial Compass
Not Yet RecruitingPhase 1
U96-CAR-T-Cells For R/R B-ALL
China30 participantsStarted 2026-07-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must voluntarily sign the informed consent form and have good compliance;
. For different indications, patients must meet the following requirements:
. The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;
. According to the standards of the National Comprehensive Cancer Network (NCCN) Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2024, 2nd Edition), it is clearly diagnosed as acute B lymphoblastic leukemia;
. According to the "Chinese Adult Acute Lymphoblastic Leukemia Diagnosis and Treatment Guidelines" (2021 Edition), one of the following conditions must be met: a. Refractory leukemia: standard induction therapy fails to achieve CR/CRi after (generally referring to 4-week regimen or Hyper-CVAD regimen) completion; b. Leukemia recurrence: patients who have achieved CR have peripheral blood or bone marrow with blast cells (proportion \> 5%) or MRD positive or extramedullary lesions; 2-2) Patients in the B-cell lymphoma group:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting toxicity (DLT)
Timeframe: Within 28 days after U96 infusion
2
Adverse Event (AE）
Timeframe: 2 years
Trial details
NCT IDNCT07511426
SponsorThe First Affiliated Hospital of Soochow University
. The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;
. According to the standards of the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2024, 3rd Edition), it is clearly diagnosed as B-cell lymphoma;
. Patients with B-cell lymphoma who have failed at least two-line treatment (one standardized chemotherapy regimen + one salvage chemotherapy) or have relapsed before screening. The previous treatment of B-cell lymphoma must include CD20 monoclonal antibody (excluding CD20-negative tumor patients) and anthracycline-based standardized treatment regimen. At least one of the following conditions must be met: a. Unable to undergo autologous hematopoietic stem cell transplantation; b. Refuse to undergo autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation;
Exclusion criteria
. Having another malignant tumor and the investigator considers that the presence of other malignant tumors may affect the current treatment;
. Any of the following conditions: positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the minimum detection limit; positive for hepatitis C antibody (HCV-Ab), and the HCV-RNA copy number is greater than the minimum detection limit; positive for anti-mycoplasma antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody;
. Existing bacterial, fungal, viral, mycoplasma or other types of infections and the investigator determines that they are difficult to control;
. Having a CNS disease other than this disease in the past or currently, such as epileptic seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease, and the investigator determines that it is uncontrollable;
. Before signing the informed consent form, having undergone cardiac angioplasty or stent placement within 12 months, or having NYHA classification III-IV grade congestive heart failure, or having myocardial infarction, unstable angina pectoris or the investigator determines that there is a clinically significant history of heart disease, or the patient's QTc interval is \> 480 ms (QTc interval calculated using the Fridericia formula), and the left ventricular ejection fraction of the heart ultrasound is \< 50%;
. Patients with primary immunodeficiency;
. Having had a severe immediate-type hypersensitivity reaction to any drug used in this study;
. Having received live vaccines within 6 weeks before screening;