eligibility_summary
Inclusion: Adults (≥18) with SLE per 2019 EULAR/ACR ≥16 weeks, SLEDAI-2K ≥10, active despite ≥3 months of ≥1 SOC immunosuppressive/biologic, background therapy stable through screening–Week 8. Exclusion: pregnant/breastfeeding or planning pregnancy during study or ≤3 months post-dose, neuropsychiatric SLE, active Class IV LN with eGFR <30, prednisone >30 mg/day, drug-induced lupus, catastrophic/severe APS within 12 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Imvotamab (IGM-2323), an intravenously administered bispecific IgM antibody (T‑cell engager). Mechanism of action: simultaneously binds CD20 on B cells and CD3 on T cells to redirect T‑cell cytotoxicity against CD20+ B cells, the multivalent IgM scaffold affords high‑avidity CD20 binding and potent complement activation (CDC), enhancing B‑cell depletion and aiming to lower pathogenic autoantibody production. Cells/pathways targeted: CD20+ naïve/memory B cells, CD3+ T cells, B‑cell/autoantibody pathway central to SLE, complement-mediated lysis and T‑cell cytotoxic pathways. Phase 1b study in severe, refractory SLE, study status: terminated (company decision).