C-CAR168 / AbelZeta Pharma - LARVOL DELTA

C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: AbelZeta Inc. | Initiation date: Jul 2025 ➔ Jan 2026

Trial initiation date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

AbelZeta Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for C-CAR168 for the Treatment of Refractory SLE, Including LN (PRNewswire) - "AbelZeta Pharma, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN)...The RMAT designation, granted under Investigational New Drug (IND) 30283, is based on promising early clinical data demonstrating the potential of C-CAR168 to address serious unmet medical needs in patients with treatment-resistant forms of autoimmune disease....AbelZeta plans to request a multidisciplinary type B meeting with the FDA to discuss the next steps in the clinical and manufacturing development of C-CAR168."

FDA event • Lupus Nephritis • Systemic Lupus Erythematosus

AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025 (PRNewswire) - P1 | N=30 | CAR-AID (NCT06249438) | "Overall, 10 patients have been treated with C-CAR168 including 7 LN patients, 1 Secondary Progressive Multiple Sclerosis (SPMS), 1 Neuromyelitis Optica Spectrum Disorder (NMOSD) and 1 Immune-Mediated Necrotizing Myopathy (IMNM) patient as of February 28, 2025; Early clinical data showed that C-CAR168 was well tolerated. Four LN patients and one SPMS patient experienced low-grade 1-2 CRS with median time to onset of 2 days post C-CAR168 treatment....Four LN patients treated with C-CAR168 reached the 6-month evaluation timepoint. All 4 achieved and remained in SRI (4), 2 patients achieved CR, and 1 PR based on Kidney Disease: Improving Global Outcomes (KDIGO) 2024 LN Response Criteria."

P1 data • Lupus Nephritis • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Systemic Lupus Erythematosus

AbelZeta Announces Upcoming Oral Presentations at LUPUS 2025 (PRNewswire) - "AbelZeta Pharma, Inc...today announced the acceptance of an abstract related to C-CAR168 for presentation at the 16th International Congress on Systemic Lupus Erythematosus ('LUPUS 2025'), taking place in Toronto, Canada on May 21-24, 2025."

P1 data • Lupus Nephritis

C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: AbelZeta, Inc.

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

AbelZeta Presents Preclinical Data from Study of C-CAR168 for the Treatment of Autoimmune Diseases at ACR Convergence 2024 (PRNewswire) - P1 | N=30 | NCT06249438 | "Potent In Vivo Cytotoxicity: In immunodeficient mouse models, a single dose of C-CAR168 demonstrated significant activity across multiple dosage levels, effectively inhibiting the growth of CD20 and BCMA single-positive or double-positive in various xenograft models....Clinical Development for C-CAR168: In an investigator-initiated trial in China targeting refractory/relapsing LN patients, 7 patients have been treated in a suboptimal dose and a potentially optimal dose. Depletion of both B cells and plasma cells in the blood in all patients were observed, accompanied by a favorable safety profile and early positive clinical signals at the suboptimal dose from patients that have had at least 3 months of follow up. Actively looking to expand into new indications such as Neuromyelitis Optica Spectrum Disorder (NMOSD), Immune-Mediated Necrotizing Myopathy (IMNM), and Systemic Sclerosis (SSc) to provide guidance for global trial to be initiated around mid 2025."

New trial • P1 data • Preclinical • Lupus Nephritis • Neuromyelitis Optica Spectrum Disorder • Systemic Sclerosis

C-CAR168 as a Novel Anti-CD20/BCMA Bispecific Autologous CAR-T Therapy for the Treatment of Autoimmune Diseases (ACR Convergence 2024) - "Based on the promising in vitro/in vivo efficacy results and safety data, C-CAR168 is being evaluated in clinical trials to treat patients with a variety of autoimmune diseases that are refractory to standard therapy."

B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2

CAR-AID: A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: RenJi Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Myositis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Systemic Lupus Erythematosus • IFNG • IL10 • IL2 • IL4 • IL6 • TNFA

CAR-AID: A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: RenJi Hospital

New P1 trial • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Myositis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Systemic Lupus Erythematosus • IFNG • IL10 • IL2 • IL4 • IL6 • TNFA