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CAR-T Cell Therapy Targeting to CD19 for R/R ALL

NCT03919240 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-04-21

No results posted yet for this study

Summary

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

Conditions

  • Acute Lymphoblastic Leukemia With Failed Remission

Interventions

BIOLOGICAL

CAR T-cell therapy

All enrolled patients will initially enter Arm A and receive CD19-targeted CAR T-cell therapy at a target dose of 5\~10×10E6 cells/kg after a lymphodepleting regimen consisting of fludarabine (30 mg/m²/day, days -5 to -3) and cyclophosphamide (300 mg/m²/day, days -5 to -3). Patients with an available eligible donor who consent to randomization will enter the RCT component and be randomized in a 2:1 ratio to Arm B1 (CAR T-cell therapy alone) or Arm B2 (CAR T-cell therapy followed by allo-HCT); all other patients will remain in Arm A.

Sponsors & Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    collaborator INDUSTRY

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • Third Military Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Depei Wu, M.D., Ph.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2027-08-30
Completion
2027-12-31

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 NCT03919240 on ClinicalTrials.gov