CD19/BCMA targeted CAR T-cells / Shanghai Yake Biotech - LARVOL DELTA

Immune remodeling enables sustained EBV clearance in B-cell and plasma cell malignancies after anti-CD19/BCMA CAR-T therapy: A post-hoc analysis (ASH 2025) - P=N/A, P1 | "Beyond B-cell depletion, CAR-T induced systemic EBV clearance, likely mediated byimmune remodeling during CRS. Enhanced EBV-specific T cell responses and supportive cellularinteractions suggest CAR-T as a promising strategy to overcome EBV-related complications in thispopulation."

IO biomarker • Retrospective data • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • CD22 • CD40 • CD8 • CXCL12 • FASLG • GAS6 • IL6 • TNFRSF14

CD19/BCMA CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus - Safety and Preliminary Efficacy Data from a Phase I Clinical Study (ASH 2023) - "After lymphodepleting chemotherapy with cyclophosphamide/fludarabine (D-4 to D-2), patients receive a single infusion of 1-2x106 CD19 CAR-T cells and BCMA CAR-T cells per kilogram of body weight at D0...All patients had active severe SLE and had received glucocorticoids, hydroxychloroquine, tacrolimus, total glucosides of paeony, merti-macrolide, leflunomide, azathioprine, methotrexate, cyclophosphamide, immunoglobulin, rituximab, belimumab, and Tetracycline before treatment with CAR-T cells, which were standard treatments that were either ineffective or difficult to withdraw.3 patients received 1x10^6/kg of each of CD19 CAR-T cells and BCMA CAR-T cells, and 9 patients received 2x10^6/kg of each of CD19 CAR-T cells and BCMA CAR-T cells 2x10^6/kg... These data suggest that CD19/BCMA CAR-T cell therapy is well tolerated and can induce rapid and durable remission in severe refractory SLE."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • Systemic Lupus Erythematosus

CO-INFUSION OF CD19/BCMA-TARGETED CAR-T CELLS ERADICATES AUTOANTIBODY-PRODUCING CELLS IN SLE PATIENTS:A PHASE 1 CLINICAL TRIAL (EBMT 2025) - P1 | "In conclusion, the current study represents a significant step forward in the treatment of SLE, offering new hope for patients with refractory SLE. The identification of memory B cells and LLPCs as the main sources of autoantibodies and their role in the pathogenesis of SLE highlight the need for targeted therapies, such as CD19 and BCMA dual-targeting CAR-T cells. The comprehensive restoration of memory B cells and plasma cells post-CAR-T therapy and the clear shift towards a more protective immune response suggest a promising therapeutic approach for SLE."

CAR T-Cell Therapy • Clinical • P1 data • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: He Huang

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Zhejiang University

CAR T-Cell Therapy • New P1 trial • Amyloidosis • Anemia • Hematological Disorders • Immunology • Vasculitis

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Zhejiang University

CAR T-Cell Therapy • Clinical • New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CD19

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Zhejiang University

CAR T-Cell Therapy • Clinical • New P1 trial • Immunology • Sjogren's Syndrome • CD19

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Zhejiang University

CAR T-Cell Therapy • Clinical • New P1 trial • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis • CD19

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Zhejiang University

CAR T-Cell Therapy • Clinical • New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD19

CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies (clinicaltrials.gov) - P1; N=120; Recruiting; Sponsor: Zhejiang University

Clinical • New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology