eligibility_summary
Include: PPMS or SPMS, prior anti-CD20 mAb, sustained disability worsening >=6 months with progression in past 2 years. Exclude: monophasic/RIS/CIS/PSS/RRMS, CNS/spinal tumors, metabolic/infectious myelopathy, genetic/non-MS progressive neuro disease, sarcoidosis, PML, prior CAR-T/gene therapy or stem cell transplant, active HBV/HCV, HIV+, primary immunodeficiency, splenectomy, major neuro disorders, significant cardiac disease, malignancy except certain cured cases.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06384976 (KYSA-7) tests: 1) KYV-101, an autologous, fully human anti-CD19 CAR T-cell therapy (cellular immunotherapy). Mechanism: patient T cells are engineered with a CD19-directed CAR to recognize and lyse CD19+ B-lineage cells, depleting naïve/memory B cells and plasmablasts/early plasma cells in blood, lymphoid tissue, and potentially CNS, this reduces B-cell antigen presentation to T cells, proinflammatory cytokines, meningeal B-cell follicles, and autoantibody production. Given after lymphodepletion with cyclophosphamide (alkylator) and fludarabine (purine analog) to reduce lymphocytes and enable CAR-T expansion. 2) Active comparator: anti-CD20 monoclonal antibody (B-cell–depleting mAb) that removes CD20+ B cells via ADCC/CDC/apoptosis (generally spares long-lived plasma cells). Targeted cells/pathways: CD19+ and CD20+ B-cell compartments, humoral immunity, B–T cell antigen presentation/costimulation, inflammatory cytokine networks, ectopic meningeal B-cell follicles implicated in progressive MS.