eligibility_summary
Adults 18–65 with: SLE (EULAR/ACR, ANA/dsDNA+, SLEDAI≥8) refractory, or relapsed/refractory GPA/MPA (CHCC, BVAS major/≥3, PR3/MPO+), or active IIM (2017 EULAR/ACR DM/PM/IMNM, MMT-8≤141 plus ≥2 CSMs, enzymes>1.5×ULN) after GC+≥2 IS, or relapsed/refractory dcSSc with ILD and active skin/ILD decline. Need adequate organ function, survival>6 mo, contraception/negative pregnancy test, consent. Exclude severe organ/CV/renal disease, other AIDs/myopathies, malignancy, recent HSCT/CAR‑T/biologics/pulse steroids/surgery/vaccine, uncontrolled infection or HBV/HCV/HIV/syphilis/TB.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06208280 (Phase 1, open-label, single-arm). Intervention: F01, a gene-modified cellular therapy consisting of 0.5–3×10^9 CAR+ natural killer (NK) cells, given after lymphodepletion with fludarabine and cyclophosphamide. Mechanisms: F01 uses a chimeric antigen receptor to redirect NK cytotoxicity and immune modulation toward disease-driving immune cells, specific CAR target not disclosed. Fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) provide lymphodepletion to enhance cell therapy activity/persistence. Targets: Effector cells are NK cells (innate immunity/CAR signaling). Intended targets are pathogenic autoreactive lymphocytes in SLE, ANCA vasculitis, IIM, and dcSSc, precise antigen/pathway not specified.