CTA313 / Imviva Biotechnologies - LARVOL DELTA

CTA313, CD19/BCMA dual targeted allo-CAR-T cell, Induces Deep B-Cell depletion and Durable Remission in Lupus Nephritis (ACR Convergence 2026) - No abstract available

CAR T-Cell Therapy • Clinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

CTA313, a Dual-Target CD19/BCMA Allogeneic (allo-) CAR-TANS Cell Therapy, Induces Durable Remission and Immune Reconstitution in Refractory Systemic Lupus Erythematosus (SLE): A Pooled Analysis of Phase 1 Studies (ACR Convergence 2026) - No abstract available

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

ALLNEW: A Basket Study of CTA313 in Participants With Active Autoimmune Diseases (clinicaltrials.gov) - P1 | N=81 | Not yet recruiting | Sponsor: Imviva Bio

New P1 trial • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Systemic Lupus Erythematosus

CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd. | Initiation date: Apr 2026 ➔ Sep 2026

Trial initiation date • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: The Children's Hospital of Zhejiang University School of Medicine

New P1 trial • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Myositis • Nephrology • Pediatrics • Renal Disease • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune Diseases (GlobeNewswire) - "The FDA cleared Phase 1b basket design will evaluate the safety, efficacy, and cellular pharmacokinetics of CTA313 across multiple B-cell-mediated autoimmune conditions, including systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis."

IND • New P1 trial • Multiple Sclerosis • Systemic Lupus Erythematosus

CTA313, CD19/BCMA dual targeted allo-CAR-TANS cell, Durable Remission in Systemic Lupus Erythematosus following Deep B-Cell depletion, Suggestive of Immune-Reset (EULAR 2026) - "Methods Patients with SLE/LN received a single administration of CTA313 treatment at 3 dose levels (DLs): DL1 3×106 CAR+ T cells/kg, DL2 6×10 6 CAR+ T cells/kg, DL3 10×106 CAR+ T cells/kg following standard dose lymphodepletion comprised of cyclophosphamide (300 mg/m2, day -5 to -3) and fludarabine (30 mg/m2, day -5 to -3)...All patients had been previously treated with steroids and immunosuppressive drugs, including hydroxychloroquine (n=18), tacrolimus (n=17), mycophenolate mofetil (n=12), cyclosporine A (n=3), thalidomide (n=4), methotrexate (n=1), telitacicept (n=3) and belimumab (n=3)...Importantly, 89% (16/18) of patients discontinued all immunosuppressive agents, and corticosteroids were tapered to ≤10 mg/day. 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..."

CAR T-Cell Therapy • Clinical • IO biomarker • Glomerulonephritis • Graft versus Host Disease • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pneumonia • Respiratory Diseases • Rubella • Systemic Lupus Erythematosus • Varicella Zoster

Imviva Biotech…announced that it will present data on CTA313, its investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy for Systemic Lupus Erythematosus (SLE), at the European Alliance of Associations for Rheumatology 2026 Congress (EULAR) in London from June 3-6, 2026 (GlobeNewswire)

Clinical data • Systemic Lupus Erythematosus

CTA313, CD19/BCMA dual targeted allo-CAR-TANS cell, Induces Deep B-Cell depletion, Supporting an Immune-Reset Mechanism for Durable Remission in Autoantibody-Mediated Diseases (ASGCT 2026) - "Methods Patients with auto-immune disease received a single administration of CTA313 treatment at 3 dose levels (DLs): DL1 3×106 CAR+ T cells/kg, DL2 6×106 CAR+ T cells/kg, DL3 10×106 CAR+ T cells/kg following standard dose lymphodepletion comprised of cyclophosphamide (300 mg/m2, day -5 to -3) and fludarabine (30 mg/m2, day -5 to -3). Among pts with a follow up ≥6 months, 60% (6/10) achieved DORIS remission, indicating durable responses. Conclusion CTA313 produces deep, durable B-cell depletion followed by a 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 suggesting durable responses in autoantibody-mediated autoimmune disease."

CAR T-Cell Therapy • Clinical • IO biomarker • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rubella • Systemic Lupus Erythematosus

CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

New P1 trial • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Imviva Biotech Presents Data Demonstrating Durable Clinical Responses from Ongoing Phase 1/2 Study of CTA313 in Systemic Lupus Erythematosus at ASGCT 2026 (GlobeNewswire) - "Among 18 evaluable patients with SLE/lupus nephritis (LN) treated with CTA313, with a median follow-up of six months: 100% achieved an SRI-4 response; 78% achieved Lupus Low Disease Activity State; 50% achieved DORIS (Definition of Remission in SLE) remission in an SLE/LN mixed cohort; 80% achieved DORIS in a non-renal SLE sub-cohort, in which 90% of those patients achieved immunosuppression-free remission."

P1/2 data • Systemic Lupus Erythematosus

Imviva Biotech…announced that it will present clinical data from its ongoing open-label Phase 1/2 study of CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy, at the American Society of Gene & Cell Therapy’s Annual Meeting (ASGCT 2026) (GlobeNewswire) - "Ben Capoccia, Director of Translational Medicine and Clinical Research at Imviva Biotech, will present results from a study of SLE patients treated with a single administration of CTA313, demonstrating rapid and profound B-cell depletion, followed by an immunologic profile consistent with an immune-reset mechanism."

P1/2 data • Systemic Lupus Erythematosus

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