CD22/CD19 CAR T / The First Affiliated Hospital of Soochow University - LARVOL DELTA

Safety and Efficacy of CD22/ CD19 CAR-T and Auto-HSCT "Sandwich" Strategy As Consolidation Therapy for Ph Negative B Cell Acute Lymphoblastic Leukemia (ASH 2023) - P2 | "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."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD22

Safety and Efficacy of CD22/ CD19 CAR-T and Auto-HSCT "Sandwich"Strategy As Consolidation Therapy for Ph Negative B Cell Acute Lymphoblastic Leukemia (ASH 2024) - P2 | "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...Four of 7 relapsed patients received allo-HSCT, 2 relapsed patients who declined allo-HSCT received Blinatumomab, and 1 patient was undergoing the chemotherapy as re-induction treatment...CD22/CD19 CAR-T resulted in deeper remission before transplantation. The new strategy may benefit patients from LFS and OS."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD22

A phase 2 trial of a "sandwich" strategy: Sequential CD22/CD19 chimeric antigen receptor T-cells therapy combined with autologous hematopoietic stem cell transplantation in patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia. (PubMed, Cancer) - P2 | "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."

Journal • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD22

CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Initiation date: Jun 2025 ➔ Jun 2026

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: 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

Phase classification • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Trial primary completion date: May 2024 ➔ Dec 2024

CAR T-Cell Therapy • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

Safety and Efficacy of CD22 and CD19 Chimeric Antigen Receptor T Cell Treatment Bridging to Autologous Stem Cell Transplantation As Consolidation Therapy for B-Cell Acute Lymphoblastic Leukemia (ASH 2022) - P1/2 | "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."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Leukemia • Oncology • Respiratory Diseases • Transplantation • CD19 • CD22

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University

CAR T-Cell Therapy • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22