eligibility_summary
Adults 18–65 with SLE (1997 ARA), active disease (SLEDAI-2K ≥8) plus BILAG A ≥1 system or B ≥2, seropositive (ANA ≥1:80 or anti-dsDNA/Sm ↑), ANC ≥1×10^9/L, Hb ≥60 g/L, LVEF ≥50%, on oral steroids + immunosuppressant/biologic ≥6 mo, women use contraception. Exclude severe drug allergy, active/recent IV infection, immunodeficiency, NYHA III/IV, CNS disease, severe/recent herpes/VZV, pregnancy/lactation, interfering skin disease, recent trials/B-cell therapy, significant labs/conditions, most cancers except cured.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06010472 (recruiting, China). Intervention: KN5501, an allogeneic anti-CD19 chimeric antigen receptor natural killer (CAR-NK) cell therapy. Patients receive lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) before CAR-NK infusion, dosing follows a 3+3 escalation. Mechanism of action: NK cells engineered with an anti-CD19 CAR bind CD19 on B-lineage cells and kill targets via NK cytotoxic pathways (perforin/granzyme and innate NK signaling), depleting autoreactive B cells and plasmablasts to reduce autoantibody production and reset B-cell compartment. Targets: CD19+ B cells (naive, memory, plasmablasts), B-cell receptor–driven autoimmunity/germinal center activity in SLE. Design: single-arm, Early Phase 1, 36 refractory moderate–severe SLE patients, primary focus on safety, with efficacy via BILAG-2004, SRI-4, LLDAS, DORIS.