CD22/CD19 CAR T

The CD22/CD19 CAR T-cell and auto-HSCT sandwich strategy represents a promising approach for the treatment of Ph-negative B-ALL in AYA and adult patients, offering high efficacy and a favorable safety profile. The trial registration is ClinicalTrials.gov identifier NCT05470777.

P2, N=40, Not yet recruiting, The First Affiliated Hospital of Soochow University | Initiation date: Jun 2025 --> Jun 2026

P2, N=37, Recruiting, The First Affiliated Hospital of Soochow University | Phase classification: P1/2 --> P2 | Trial completion date: Dec 2025 --> Jul 2039 | Trial primary completion date: Dec 2025 --> Jul 2026

P2, N=40, Not yet recruiting, The First Affiliated Hospital of Soochow University

P1/2, N=35, Recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P1/2, N=35, Recruiting, The First Affiliated Hospital of Soochow University | Trial primary completion date: May 2024 --> Dec 2024

Afterwards, autologous CAR T-cells targeting CD22 and CD19 (CAR-T 1, co-stimulatory molecule was 4-1BB and infusion dose was 5×106/kg, respectively) were sequential infused after lymphodepletion chemotherapy with fludarabine and cytophosphamide...Two patients with Ph- B-ALL relapsed at 5 and 6 months after auto-HSCT and were treated with blinatumomab... Our preliminary study demonstrated that CD22/CD19 CAR-T and Auto-HSCT "Sandwich" strategy as a consolidation strategy showed favorable safety and efficacy in Ph- B-ALL. CD22/CD19 CAR-T resulted in deeper remission before transplantation. The new strategy may benefit patients from LFS and OS.

The main purpose of this study is to observe the safety and efficacy of CD22/CD19 CAR-T bridging to autologous stem cell transplantation (auto-HSCT) in B-ALL patients...Afterwards, autologous CAR T-cells targeting CD22 and CD19 (co-stimulatory molecule was 4-1BB and infusion dose was 5×106/kg, respectively) were sequential infused after lymphodepletion chemotherapy with fludarabine and cytophosphamide... Our preliminary study demonstrated that autologous CD22 and CD19 CAR-T cell infusion bridging auto-HSCT as a consolidation strategy showed favorable safety and efficacy in B-ALL. The harvest of autologous stem cells after CAR-T cell therapy allows the persistence of CAR-T cells in the stem cells, which may explain the persistence of CAR-T cells after autologous transplantation despite the myeloablative conditioning regimen used in our study.

P1/2, N=35, Recruiting, The First Affiliated Hospital of Soochow University