eligibility_summary
Incl: 2–17 y, SRNS (KDIGO 2021) with either ≥6 mo CNI nonresponse, CNI contraindications, or inadequate/relapsing response after ≥2 immunosuppressants (CNI + another), biopsy MCD or FSGS, consent. Excl: eGFR<60, recent stroke/seizure/CNS disease, genetic nephropathy, IgA/MN/MPGN, serious cardiac disease, active HBV/HCV/HIV/syphilis/CMV, cytopenias or liver dysfunction, cancer, pregnancy, other trial <1 mo, RTX/cyclo <3 mo, PI decision, live vaccine <4 wk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests blinatumomab, a bispecific T‑cell engager (BiTE) antibody construct, in pediatric CNI‑resistant/intolerant steroid‑resistant nephrotic syndrome (MCD/FSGS). Mechanism: binds CD19 on B cells and CD3 on T cells, recruiting cytotoxic T cells to deplete CD19+ B cells and modulate aberrant humoral immunity. Targets: CD19+ B cells (naive, memory, plasmablasts) and CD3+ T cells, downstream effects on B/T costimulation, antigen presentation, autoantibody production, and cytokine signaling implicated in SRNS. Design: open‑label, single‑arm Phase 1 (n=6), two 5‑day IV cycles (5 µg/m²/day, max 9 µg/day). Primary endpoint: proteinuria remission, secondary: safety, immune markers, renal function.