Clinical Trial

Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL

Suspended Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
According to the new regulations of China, newly launched clinical trials involved CAR-T cells must be apporved first by China National Center for Biotechology Development.
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. We conduct pre-auto-HSCT immunotherapy to achieve MRD negative remission, then perform auto-HSCT followed by CD22/CD19 CAR-T "sandwich " strategy in AYA and adult patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Suspended 2026-05-30
critical Reason stopped changed: — → According to the new regulations of China, newly launched clinical trials involved CAR-T cells must be apporved first by China National Center for Biotechology Development. 2026-05-30
Trial Details
NCT Number NCT06985498
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Acute Lymphobkastic Leukemia
Enrollment 40 participants
Start Date 2025-06-01
Primary Completion 2029-06-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-29