eligibility_summary
Adults 18–70 with CD19+ B cells and adequate organ function, contraception/consent. R/R: PMN (biopsy‑proven, protein ≥3.5 g/d, eGFR ≥45), IgAN (biopsy‑proven, protein ≥1 g/d or rapid eGFR loss/relapse, eGFR ≥30), ANCA‑vasculitis (ACR/EULAR, MPO/PR3+, BVAS≥15, eGFR ≥15). Exclude severe allergy/infection, CNS/heart disease, active HBV/HCV/HIV/syphilis, malignancy, ESRD, pregnancy, plus PMN secondary/diabetes, secondary/crescentic IgAN, or AAV with eGFR<15 or ventilated alveolar hemorrhage.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KN5501, an anti-CD19 chimeric antigen receptor natural killer (CAR-NK) cell therapy (biologic/cellular immunotherapy). Mechanism: NK cells are genetically engineered to express a CAR that binds CD19 on B cells, upon engagement, NK cytotoxic pathways (perforin/granzyme, death receptor signaling) eliminate CD19+ B cells/plasmablasts, aiming to suppress autoantibody production and B cell–driven inflammation in immune nephropathies. Conditioning: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) for lymphodepletion to enhance CAR-NK expansion/persistence. Targets: CD19+ B-cell lineage and humoral autoimmune pathways in membranous nephropathy, IgA nephropathy, and ANCA-associated vasculitis.