eligibility_summary
Adults 18–65 with progressive MS (2017 McDonald, 2014 Lublin), VZV immunity and EBV Ab+, adequate labs/organ function and stable vitals, negative key infection screens, contraception and consent. Exclude NMOSD/MOGAD, investigational therapy or new DMTs (anti‑CD20 <9 mo, Mavenclad ≤9 mo), other serious neurologic disease, cirrhosis, cancer, active infection, renal ≥stage 3, moderate+ asthma/COPD, cardiac disease/QTc, anticoagulants, seizures, prior HSCT/CAR‑T/gene/solid Tx, allergy to study drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: KYV-101, an autologous fully human anti-CD19 CAR-T cell therapy, administered after standard lymphodepletion with bendamustine (alkylating agent). Mechanisms: KYV-101 reprograms patient T cells to express a CD19-directed CAR, enabling cytotoxic killing of CD19+ B-lineage cells (naive/memory B cells and plasmablasts) in blood, lymphoid tissues, and potentially CNS. This aims to deeply deplete B cells and reset immune dysregulation in non-relapsing progressive MS (SPMS/PPMS). Expected immunologic effects: reduce B-cell antigen presentation to T cells, lower pro-inflammatory cytokines, disrupt meningeal B-cell follicles, deplete EBV-reservoir B cells, and curb autoantibody precursors, indirectly modulates T-cell and myeloid activation. Lymphodepletion (bendamustine) reduces native lymphocytes to enhance CAR-T expansion/persistence. Targets/pathways: CD19+ B cells, humoral autoimmunity, B–T antigen-presentation/costimulation axis, EBV-related B-cell pathology.