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CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

NCT05470777 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-06-05

No results posted yet for this study

Summary

Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. The investigators first conducted CD22/CD19 CAR T-cells and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.

Conditions

Interventions

COMBINATION_PRODUCT

CD22/CD19 CAR T and auto-HSCT "sandwich" strategy

The patients received sequential infusion of CD22 and CD19 CAR-T cells (co-stimulatory molecule was 4-1BB and infusion dose was 5\*10\^6/kg respectively) after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after CAR-T infusion. Modified BuCy as conditioning regimen for Auto-HSCT was used 4 weeks after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after Auto-HSCT. Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.

Sponsors & Collaborators

  • National Natural Science Foundation of China(Grant No. 81970138)

    collaborator UNKNOWN

  • Jiangsu Province Natural Science Foundation of China (Grant No. BK20210091)

    collaborator UNKNOWN

  • Jining Medical University

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Suzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-19
Primary Completion
2026-07-21
Completion
2039-07-21

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 NCT05470777 on ClinicalTrials.gov