eligibility_summary
Adults 18–65 with adequate marrow, liver, renal, coag/cardiac function, birth control and consent. Refractory cohorts: pSS (ESSDAI ≥5), systemic sclerosis (ACR 2013, ILD with FVC/DLCO <70% or progressive), IIM (EULAR/ACR 2017, muscle weakness criteria), RA (ACR/EULAR 2010, active, EULAR refractory). Exclude allergy, active infection, CNS or heart disease, cancer, ESRD, HBV/HCV/HIV/syphilis, pregnancy, pSS cirrhosis/AA/MDS/MPD, IIM drug/inclusion body/tumor, RA class 4.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: anti-CD19 chimeric antigen receptor (CAR) natural killer (NK) cells (gene‑modified cellular immunotherapy, biologic), infused after lymphodepleting conditioning with fludarabine (purine analog) and cyclophosphamide (alkylating agent). Mechanism: CAR redirects NK cytotoxicity to CD19, enabling MHC‑independent recognition and killing (perforin/granzyme) of CD19+ B‑cell subsets (naive, memory, plasmablasts). Intended effects: deplete autoreactive B cells, reduce autoantibody production, antigen presentation, and B–T cell costimulation, dampening downstream inflammatory cascades and aiming to restore immune tolerance. Targets/pathways: CD19 on B cells, B‑cell–driven humoral immunity and germinal center activity in pSS, systemic sclerosis (incl. ILD), idiopathic inflammatory myopathies, and refractory rheumatoid arthritis. Phase 1, single‑arm dose escalation.