NCT06985498

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

Safety and Efficacy of Pre-Auto-HSCT Immunotherapy Combined With Auto-HSCT Followed by the CD22/CD19 CAR-T Sandwich Strategy for AYA and Adult B-cell Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphobkastic Leukemia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sandwich stratergy	Newly diagnosed patients first receive standard chemotherapy as induction therapy, followed by immunotherapies as consolidation therapy. Relapsed or refractory patients directly receive immunotherapies. Minimal Residual Disease （MRD）was evaluated by multicolor flow cytometry （MFC-MRD）and next-generation sequencing of IgH rearrangement （NGS-MRD）after immunotherapies. Immunotherapies includes CD19-directed CD3 T-cell engager, inotuzumab ozogamicin (INO) and CD22/CD19 CAR-T cell. In principle, these three treatment options are administered sequentially. Once patients achieve dual negativity of MFC-MRD and NGS-MRD, no further immunotherapies are applied, and patients proceed to autologous stem cell mobilization and collection. Prior to autologous stem cell transplantation (Auto-HSCT), patients receive high-dose MTX for CNS prophylaxis. CD22/CD19 CAR-T cells are infused 2 days after stem cell infusion. Patients with ph positive and ph-like (ABL class) B-ALL require TKIs.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-09-01
• First posted: 2025-05-22
• Last updated: 2026-03-24