Study of CT103A CAR-T Cell Therapy for Adults with Relapsed or Refractory Antibody-Associated Nervous System Autoimmune Diseases

What this Trial Is About

This trial investigates antibody-mediated inflammatory diseases of the nervous system, which are autoimmune conditions where the bodys immune system attacks parts of the nervous system. The study focuses on eight specific diseases including Neuromyelitis Optica Spectrum Disorder, Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Idiopathic Inflammatory Myopathy, Multiple Sclerosis, Autoimmune Encephalitis, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, and POEMS Syndrome. The aim is to evaluate the safety and effectiveness of a novel treatment involving CT103A cells, a form of CAR-T cell therapy targeting B-cell maturation antigen BCMA to reduce harmful plasma cells causing these diseases. Participants will receive CT103A cells after a preparatory treatment called lymphodepletion, which involves drugs cyclophosphamide and fludarabine to reduce certain immune cells. The CAR-T cell treatment is given intravenously with different dose levels tested starting from 0.5 million CAR-T cells per kilogram of body weight, potentially increasing to higher or lower doses based on safety and effectiveness observed. The study includes an early-phase design where dosing and safety are carefully assessed in small groups before progressing. Participants will be monitored closely for side effects and treatment impact, including vital signs, physical exams, lab tests, heart function tests, and antibody levels for up to two years after treatment. The main focus is on identifying any dose-limiting toxicities within 28 days of infusion and tracking adverse events for two years. Additional long-term monitoring of the therapys behavior in the body will continue for up to 15 years. Throughout the study, participants will provide informed consent and undergo various assessments to evaluate safety and treatment effects.

Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System