eligibility_summary
Adults 18–65 with relapsed/refractory SLE, dcSSc with ILD, AAV, IIM, or Sjögren’s meeting classification/activity criteria, prior inadequate response to ≥3 mo glucocorticoids plus ≥2 immunosuppressants, adequate organ function, survival >6 mo, contraception. Key exclusions: malignancy, severe organ/CNS disease or lupus crisis, low Ig, recent B‑cell/IVIG/high‑dose steroids/biologics, serious infection (HBV/HCV/HIV/TB/syphilis), major CV disease, pregnancy, live vaccines, psychiatric illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: autologous CD19-directed CAR-T cells (gene-modified cellular immunotherapy), given as a single IV infusion in a 3+3 dose-escalation design. Indications: relapsed/refractory SLE, diffuse cutaneous systemic sclerosis, ANCA-associated vasculitis, idiopathic inflammatory myopathy, and Sjogren’s syndrome. Mechanism: engineered T cells recognize CD19 on B-lineage cells and induce cytotoxic depletion, producing deep B-cell aplasia to reduce autoantibody production and B cell–T cell costimulation. Targets: CD19+ naive/memory B cells and plasmablasts, humoral autoimmunity pathways (BCR signaling, pathogenic antibodies such as anti-dsDNA, PR3/MPO-ANCA, anti-Ro/SSA).