Allogeneic UCB-derived CAR-T for B-ALL (NCT07256353) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Allogeneic UCB-derived CAR-T for B-ALL
China50 participantsStarted 2025-12-01
Plain-language summary
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the allogeneic, umbilical cord blood-derived CAR-T cell product.
The main questions it aims to answer are:
1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and UCAR-T-related adverse events (AEs) after the UCAR-T cell infusion?
2. Which dose level is the optimal biological dose (OBD)?
3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?
Participants will:
1. May receive lymphodepletion chemotherapy if clinically indicated: fludarabine (30 mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300-500 mg/m²/d, days -5 and -4).
2. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1.
3. Receive UCAR-T cells infusion on Day 0.
4. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
5. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after UCAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Who can participate
Age range
18 Years – 70 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:
* Age 18 to 70 years inclusive at the time of signing informed consent.
* Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.
* CD19 expression or CD20 confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.
* Life expectancy ≥8 weeks in the opinion of the investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status score \<4.
* Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as:
* Creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN)
* Total bilirubin ≤- 1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤- 2.5 × ULN is acceptable)
* For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective…
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
The incidence rate of Dose limited toxicity (DLTs)
Timeframe: Up to 28 days after infusion
2
the rate of adverse events
Timeframe: Up to 28 days after injection
Trial details
NCT IDNCT07256353
SponsorThe General Hospital of Western Theater Command