eligibility_summary
Adults 18–70 with progression despite RAS blockade, steroids ≤40 mg/d (stable), other IS meds stable ≥4 wks. LN: SLE ACR≥10, recent class III/IV±V biopsy, UPCR≥1.5–≤7 g/d, autoAb+, refractory to ≥2 regimens. pMN: recent biopsy, UPCR≥3.5, anti‑PLA2R+, refractory/intol to ≥1 induction. Exclude: eGFR<45/dialysis, transplant/immunodef, major hepatic/pulm/cardiac disease, cytopenias, infection incl HIV/HBV/HCV/TB, pregnancy, recent cancer/surgery, prior cell Rx, CNS disease/APS, prohibited/recent investigational drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06557265: Phase 1/2, single-arm study in refractory lupus nephritis or primary membranous nephropathy testing NKX019—an off-the-shelf allogeneic CD19-directed chimeric antigen receptor natural killer (CAR-NK) cell therapy (cellular immunotherapy/adoptive cell therapy). Conditioning uses lymphodepleting chemotherapy: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent), then three NKX019 doses. Mechanism: engineered NK cells recognize CD19 and kill B-lineage cells, aiming to deplete autoreactive B cells/plasmablasts and reduce pathogenic autoantibodies. Targets/pathways: CD19+ B-cell compartment, humoral autoimmunity.