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

NCT07072494 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CD19 CAR-T cells injection

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.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-19
Primary Completion
2027-03-19
Completion
2027-08-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07072494 on ClinicalTrials.gov