eligibility_summary
Adults 25–70 with progressive MS (2017), CSF OCBs/↑IgG index, EDSS 3–7, and disability progression in past 2 yrs, adequate heme/renal/hepatic function, VZV IgG+, contraception, vascular access. Exclude: stable on DMT, relapse ≤2 yrs, AQP4/MOG+, unable CSF/MRI, prior transplant/CAR‑T/mitox/cladribine/alemtuzumab, need anticoag or IgG<600, active HBV/HCV/HIV/TB/PML, immunodef/splenectomy, major cardiac disease/malignancy, serious illness, recent surgery, pregnancy, or unwilling long‑term follow‑up.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label trial of KYV-101 in treatment-refractory progressive MS. KYV-101 is an autologous, fully human anti-CD19 CAR T-cell therapy (living cell immunotherapy) engineered to recognize CD19 and eliminate CD19+ B-lineage cells (naive/memory B cells and plasmablasts), aiming to suppress B cell–driven autoimmunity, reduce intrathecal IgG, and clear CSF oligoclonal bands, CNS penetration is assessed. Two dose cohorts: 0.33×10^8 and 1×10^8 CAR+ T cells. Lymphodepletion uses fludarabine (purine analog antimetabolite inhibiting DNA synthesis) and cyclophosphamide (alkylating agent causing DNA crosslinks) to enhance CAR T expansion. Targets/pathways: CD19+ B cells, humoral antibody pathways in MS, CNS B-cell niches, PD/PK track CAR T levels, B-cell counts, cytokines.