eligibility_summary
Eligibility: Mother: chose BRIUMVI, RMS (CIS, RRMS, active SPMS), willing to breastfeed/pump and exclusively pump for 24 h after IV dose, plans to keep breastfeeding during study. Infant: GA ≥35 wks, birthweight and current weight >10th percentile. Exclude: maternal infection/inability to breastfeed, prior breast surgery/mastectomy, mastitis/active infection at Day 1, use of risky milk-transfer drugs (e.g., aspirin, tetracyclines, fluoroquinolones). Infant: significant illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: BRIUMVI (ublituximab), an FDA‑approved, glycoengineered chimeric IgG1 monoclonal antibody against CD20, no investigational intervention is given—this is an observational lactation PK study with breast milk sampling up to 24 hours post IV dose. Mechanism of action: Binds CD20 on B lymphocytes and depletes them primarily via enhanced antibody‑dependent cellular cytotoxicity, and also through complement‑dependent cytotoxicity and apoptosis, reduces B‑cell–mediated antigen presentation, cytokine production, and pathogenic humoral activity relevant to MS. Targets: CD20+ pre‑B to mature B cells (not plasma cells). Pathways/cells affected: B‑cell lineage and downstream humoral immune pathways/B‑cell receptor–driven immune activation. Purpose: quantify ublituximab presence and concentration in breast milk of breastfeeding participants treated for relapsing MS.