CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study

Sponsor
Zhujiang Hospital
Study ID
NCT07072494
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19 CAR-T cells injection — DRUG
    Lymphodepleting pre-treatment will begin one week before the CAR-T cell infusion to reduce the burden of abnormal immune cells in the body, creating a favorable environment for the infused CAR-T cells. The suggested pre-treatment regimen is based on the FC regimen (Fludarabine + Cyclophosphamide).After the pre-treatment, patients will undergo CAR-T cell infusion, where the genetically modified T-cells are infused back into the patient's body.

Study Details

This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.

Key Dates

First listed
Jul 18, 2025
Start date
Jul 19, 2025
Status verified
Feb 2025
Primary completion
Mar 19, 2027
Completion
Aug 19, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Consolidation therapy with CAR-T cells was performed after induced remission
    For autologous intravenous infusion only, the recommended dose is 0.5×108 CAR-T live cells, and the dose range is 0.25\~0.5×108 CAR-T live cells (±20%, i.e. 0.2-0.6×108 CAR-T live cells)

Primary Outcome Measure

Leukemia-Free Survival(LFS) [ Time Frame: From Chimeric Antigen Receptor T-Cell infusion to relapse or death, assessed up to 12 months ]

Central Contacts

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