eligibility_summary
Include: 18–55 with active relapsing MS, consent, read English, walk ≥25 ft/stand 30 s, not pregnant/using contraception, no cog impairment. Exclude: non‑relapsing MS, allergy to ublituximab/anti‑CD20, other neuro disease, liver disease, serious/chronic infections (incl PML), immunodeficiency, severe psych/medical illness, recent live vaccine/infection, prohibited MS/immunosuppressive meds, recent fracture/Botox/major ortho/cardiac events, unstable lung disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early Phase 1, single-arm, 48-week treatment in 25 adults with relapsing MS assessing gait, fall risk, disability, cognition, and serum neurofilament light. Intervention: Ublituximab (Briumvi) — a glycoengineered chimeric IgG1 anti-CD20 monoclonal antibody (immunotherapy). Mechanism: Selective depletion of CD20-expressing pre-B and mature B lymphocytes via enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), reduces B-cell antigen presentation to T cells, proinflammatory cytokine secretion, and pathogenic antibody production, thereby dampening CNS neuroinflammation. Targets: CD20+ B cells, downstream modulation of B-cell/T-cell crosstalk and inflammatory pathways implicated in MS.