eligibility_summary
Adults 18–70 with SSc, IIM, or AAV meeting ACR/EULAR criteria and active, refractory disease: SSc with severe/active skin or ILD plus ANA ≥2×ULN and ≤10 yrs disease, IIM with myositis Ab+, MMT-8<136, CK/aldolase ≥1.5×ULN and MRI/EMG/biopsy evidence, AAV (GPA/MPA) PR3/MPO-ANCA+ with BVAS activity. Stable meds. Exclude renal/hepatic/pulmonary/cardiac disease, severe ILD, cytopenias, infections, pregnancy, recent cancer, prior cell therapy, CNS disease, plus disease-specific exclusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06733935 (Phase 1/2). Intervention: NKX019, an investigational allogeneic CD19-directed chimeric antigen receptor natural killer (CAR NK) cell therapy (adoptive cell immunotherapy), given after lymphodepleting chemotherapy with fludarabine (purine analog, lymphocyte-depleting) and cyclophosphamide (alkylating immunosuppressant). Mechanism of action: NKX019 CAR endows NK cells to recognize CD19 and trigger NK cytotoxicity (perforin/granzyme) to deplete CD19+ B cells, aiming to suppress pathogenic autoantibody production and B cell–driven inflammation. Targets: CD19+ B cells/humoral immune pathway (including autoreactive and ANCA-producing B cells). Indications: systemic sclerosis, idiopathic inflammatory myopathies, and ANCA-associated vasculitis.