eligibility_summary
Inclusion: adults 18–75 with biopsy‑proven primary membranous nephropathy, BP ≤140/90, stable ACEI/ARB ≥4 wks, able to comply. Exclusion: secondary MN, uncontrolled BP, ≥50% proteinuria drop in past 6 mo, renal replacement, T1DM or biopsy‑proven diabetic nephropathy, TB history, active infections, severe mAb allergy, recent live vaccine/surgery/trial, pregnancy/lactation/no contraception, serious uncontrolled disease, substance abuse, HBV/HCV/immunodeficiency, CD4<300, other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05668403 tests B007, a recombinant humanized anti‑CD20 monoclonal antibody (biologic, subcutaneous), in adults with primary membranous nephropathy. Doses: 350, 700, or 1000 mg on Days 1 and 15 (Phase I, sequential cohorts). Mechanism of action: binds CD20 on mature B lymphocytes to deplete B cells via immune effector functions (e.g., ADCC/CDC/apoptosis), reducing pathogenic autoantibody production. Targets: CD20+ B cells and the humoral autoimmune pathway that drives glomerular immune complex deposition and proteinuria in membranous nephropathy, indirect reduction of antibody‑secreting cells by removing their CD20+ precursors (CD20 not expressed on long‑lived plasma cells). The study evaluates safety, tolerability, PK/PD, and preliminary efficacy.