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Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients

NCT06343090 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2026-03-10

No results posted yet for this study

Summary

This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.

Conditions

Interventions

PROCEDURE

hematopoietic stem-cell transplantation

allo-HSCT

DRUG

CD22 CAR T cells

humanized CD22 CAR T cells

DRUG

CD19 CAR T-cell

Murine-derived CD19 CAR T cells

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

    collaborator OTHER

  • Shanghai Liquan Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Central People's Hospital of Zhanjiang

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Beijing GoBroad Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2042-12-01
Completion
2043-09-30

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 NCT06343090 on ClinicalTrials.gov