eligibility_summary
Adults 18–65 with moderate–severe refractory SLE (2019 EULAR/ACR), ANA/dsDNA/Sm+, SLEDAI-2K ≥8, after adequate steroids/antimalarials/immunosuppressants and ≥1 biologic, stable steroids, adequate counts (ANC ≥1.5×10^9/L, Hb ≥80 g/L, PLT ≥50×10^9/L) and organ function (ALT/AST ≤2.5×ULN, bili ≤1.5×ULN, CrCl ≥50 mL/min, SpO2 ≥92%, LVEF ≥50%), contraception/consent. Exclude severe nephritis, CNS, severe lung/cardiac disease, TB, HBV/HCV, HIV/syphilis, recent restricted therapies/transplant, pregnancy, prohibited meds, serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial tests F01, an allogeneic cellular immunotherapy: chimeric antigen receptor–engineered NK (CAR‑NK) cells (0.5–3×10^9) administered after lymphodepletion with fludarabine (purine analog, DNA synthesis inhibitor) and cyclophosphamide (alkylating agent). Mechanism: CAR‑NK cells are redirected via a synthetic CAR to recognize a disease-relevant antigen (target not disclosed) and kill antigen‑expressing cells through NK cytotoxic pathways (perforin/granzyme, CAR signaling), aiming to remove autoreactive immune cells driving SLE. Targeted cells/pathways: antigen‑bearing pathogenic immune cells (e.g., autoantibody‑producing populations), NK effector pathways, conditioning depletes host lymphocytes to enhance CAR‑NK engraftment/expansion.