CTA313 / Nanjing Bioheng Biotech - LARVOL DELTA

Imviva Biotech…announced that its abstract detailing clinical results ongoing Phase 1/2 trial in systemic lupus erythematosus (SLE) for CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy, has been accepted as a late-breaking short oral presentation at the 15th European Lupus Meeting (ELM 2026) (GlobeNewswire) - "As of the interim data cutoff on February 6th, 2026, 24 patients have been enrolled, including 14 patients (58.3%) with lupus nephritis. At a median follow-up of 6 months, CTA313 demonstrated robust clinical efficacy with 100% of patients achieving SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response, with 73.7% achieving LLDAS (Low Lupus Disease Activity State), and 42.1% achieving DORIS (Definition of Remission in SLE) remission at the last follow-up with a deepening trend. Additionally, 83.3% of patients achieved immunosuppression-free remission or glucocorticoid dose ≤10 mg/day."

Late-breaking abstract • P1/2 data • Systemic Lupus Erythematosus

CTA313, CD19/BCMA dual targeted allo-CAR-T cell, Durable Remission in Systemic Lupus Erythematosus following Deep B-Cell depletion, Suggestive of Immune-Reset (LUPUS 2026) - "Among pts with a follow up >= 6 months, 60% (6/10) achieved DORIS remission. Conclusions CTA313 produces deep, durable B-cell depletion followed by predominantly naïve B-cell and immunoglobin repopulation, sustained suppression of pathogenic autoantibodies, and antiviral vaccine titers—an immunologic profile consistent with an immune-reset mechanism that may enable prolonged remission in autoantibody-mediated autoimmune disease."

CAR T-Cell Therapy • Clinical • Late-breaking abstract • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Daishi Tian | N=27 ➔ 36

Enrollment change • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • Pain • LRP4

CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Daishi Tian

New P1 trial • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • Pain • LRP4

Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases. (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

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