eligibility_summary
Inclusion: Adults 18–65 with refractory SLE (Hybrid‑SLEDAI ≥8 with ≥6 clinical and ≥1 BILAG A or 2 B), ANA/dsDNA/Sm positive. If LN: active class III/IV±V, UPCR ≥1.5 and ≤7 g/day, steroids stable ≤20 mg with taper, negative SARS‑CoV‑2, contraception. Exclusion: eGFR <45, dialysis, proteinuria >7 g/d, major liver/pulmonary/cardiac/hematologic disease, active infection (HIV/HBV/HCV/TB), malignancy <5y, prior cell therapy, recent surgery, CNS SLE, overlapping autoimmune affecting outcomes, prohibited meds/hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm study in SLE ± lupus nephritis testing: 1) NKX019, a biological/adoptive cell therapy consisting of allogeneic CD19-directed CAR NK cells (IV, 1×10^9). Mechanism: engineered NK cells use a CD19-specific CAR to recognize and kill CD19+ B-lineage cells via NK cytotoxicity (perforin/granzyme), aiming to deplete autoreactive B cells/plasmablasts and reset humoral autoimmunity. 2) Cyclophosphamide lymphodepletion (alkylating chemotherapy, non-experimental) to reduce host lymphocytes and improve CAR NK expansion/persistence. Targets/pathways: CD19+ B cells, BCR/autoantibody production, germinal center activity, and immune complex–mediated inflammation relevant to SLE/LN.