eligibility_summary
Eligible: ages 3–24 with multidrug‑dependent or ‑resistant nephrotic syndrome ≥6 months (requiring ≥2 of prednisone, MMF, CNI, dependence=relapses on/after dual therapy, resistance=no antiproteinuric response to steroid+CNI/MMF, steroid resistance=no remission after 6 wks prednisone 60 mg/m²), or post‑transplant FSGS recurrence, consent/assent. Exclude: positive ANA/nDNA/ANCA, low C3, eGFR<60, pregnancy, cancer, HBV/HCV, CD20<2.5%, past 6 mo rituximab/cyclophosphamide.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rituximab biosimilar ABP 798 (chimeric anti‑CD20 monoclonal antibody, B‑cell–depleting via ADCC/CDC/apoptosis) plus daratumumab (human IgG1κ anti‑CD38 monoclonal antibody, plasmablast/plasma‑cell–depleting via ADCC/CDC/apoptosis and immunomodulation). Mechanistic intent: dual blockade of humoral immunity—eliminate CD20+ B cells and CD38+ antibody‑producing cells to prevent maturation/escape and shut down the stimulatory cascade sustaining disease. Targets/pathways: CD20+ B lymphocytes, CD38+ plasmablasts/plasma cells, adaptive immune co‑stimulatory axis (CD80/CD40) implicated as triggers, indirect rebalancing of T‑reg/effector responses. Population: pediatric/young adult multidrug‑dependent or resistant nephrotic syndrome and post‑transplant FSGS relapse. Design: single‑arm Phase II before–after trial assessing maintenance of drug‑free remission.