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Allogeneic UCB-derived CAR-T for B-ALL

NCT07256353 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • B-Cell Acute Lymphoblastic Leukemia, Adult

Interventions

DRUG

allogeneic umbilical cord blood-derived CAR-T

intravenous injection of allogeneic umbilical cord blood-derived CAR-T

Sponsors & Collaborators

  • Chengdu Ucello Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • The General Hospital of Western Theater Command

    lead OTHER

Principal Investigators

  • Hai Yi, M.D. & Ph.D. · The General Hospital of Western Theater Command

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07256353 on ClinicalTrials.gov