At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years inclusive
- ✓AQP4-IgG-positive NMOSD with at least one immunosuppressant for >1 year and poorly-controlled symptoms, plus ≥2 relapses in last 12 months or ≥3 relapses in last 24 months with ≥1 in preceding 12 months
- ✓MG with positive abnormal antibody, MG-ADL score ≥6, MGFA classification II-IV, ≥1 year immunosuppressant therapy with poor control, and requirement for plasma exchange or IV gamma globulin maintenance
- ✓CIDP with positive abnormal antibodies, INCAT disability scale score 2-9, standardized first-line therapy >3 months with poor control or intolerance to standard treatments
- ✕Inadequate mononuclear cells without mobilization for CAR-T manufacturing
- ✕History of autoimmune hemolytic disease
- ✕History of solid organ transplantation
- ✕Alemtuzumab within 6 months prior to apheresis; fludarabine or cladribine within 3 months prior to apheresis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
In Brief
A Early Phase 1 clinical trial evaluating CT103A cells and Cyclophosphamide and fludarabine for Autoimmune Diseases and 9 related conditions. Currently recruiting, targeting 36 participants across 1 site.
Detailed Summary
Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed/refractory antibody-mediated idiopathic inflammatory diseases.
Study Details
Timeline
Interventions
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT103A cells, during which cyclophosphamide will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT103A cells by intravenous (IV) infusion. The initial dose of 0.5×10\^6 CAR+ T cells/kg will be infused on day 0.
Subjects will receive one 3-day cycle of lymphodepletion starting 4 days prior to CT103A infusion on Day 0. Subjects will be given IV infusion of cyclophosphamide 300 mg/m2/day on day -4, -3 and -2, and fludarabine 30 mg/m2 over 30 minutes administered immediately after cyclophosphamide.