eligibility_summary
Part 1: SLE (2019 EULAR/ACR) with biopsy-proven ISN/RPS 2003 Class III/IV ± V LN (biopsy ≤1 yr, if eGFR 35–<45, biopsy ≤6 mo and <50% sclerosis), UPCR >1 g/g (24 h), eGFR ≥45 (or 35–<45 with above), and inadequate response/intolerance to ≥3 mo SOC. Exclude RPGN, >50% sclerosis, dialysis, or transplant. Part 2: completed Part 1, exclude prohibited meds (CNIs, alkylators, non-study biologics) or LN progression. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06064929 (Phase 1b, open-label, single-arm) in adults with active lupus nephritis. Intervention: Felzartamab (HIB202/BIIB148/MOR202/TJ202) — an IV anti‑CD38 monoclonal antibody (IgG1) immunotherapy. Mechanism of action: Binds CD38 on antibody‑secreting cells (plasma cells/plasmablasts) and depletes them via Fc‑mediated cytotoxicity/phagocytosis (and complement), lowering pathogenic autoantibody production and immune‑complex deposition in glomeruli. Targets: CD38+ plasma cells, downstream impact on humoral autoimmunity, immune complexes, and renal inflammation. Design: Two IV treatment courses separated by a 28‑week off‑treatment period, background standard of care continues. Endpoints: Safety (AEs), effects on proteinuria and creatinine, complete response rates, PK, and anti‑drug antibodies. Status: Recruiting.