eligibility_summary
Eligibility: Adults 18–65 with SLE (2019 ACR/EULAR), anti-dsDNA+ or low C3/4, SLEDAI-2K≥8, refractory despite steroids >1 mg/kg/d plus ≥2 immunomodulators ≥6 mo, adequate labs/organ function, contraception. Exclude: severe nephritis/crises, CNS disease, pregnant/lactating, active HBV/HCV/HIV/CMV/TB, immunodeficiency/IgA def., interfering skin disease, prior cell/gene/CD19 therapy, recent live vaccine/surgery/B-cell therapy/plasmapheresis/trials, transplants, or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm, open-label trial in refractory/relapsed SLE testing anti-CD19 CAR-NK cells. Drug/interventions: gene-modified cellular immunotherapy using natural killer cells engineered with a chimeric antigen receptor against CD19, preceded by lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Dosing: CAR-NK infusions on Days 0, 3, and 6. Mechanism: CAR-directed recognition of CD19 triggers NK cytotoxicity (perforin/granzyme, cytokines) to deplete CD19+ B cells/plasmablasts, aiming to reduce autoantibody production and B cell–driven inflammation. Targets: CD19 on B-lineage cells, B-cell/CD19 signaling axis, NK effector pathways. Primary goal: assess safety/efficacy in refractory SLE.