eligibility_summary
Adults ≥18 with adequate kidney/liver/heart/lung function, contraception, and COVID-19 vaccination. SLE: 2019 criteria, autoantibodies, active disease, failed steroids + ≥2 drugs. SSc: 2013 criteria, SSc Abs, rapid progression, failed ≥2. DM/PM: 2017 criteria, active myositis/ILD, myositis Ab, weakness, failed steroids + ≥2. Exclude: severe cytopenias/organ failure, uncontrolled illness, active infections, prior anti‑CD19/gene therapy/transplant, pregnancy, cancer, live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Single-dose autologous anti-CD19 CAR T-cell therapy (gene-modified cellular immunotherapy/ATMP). Patient CD4/CD8 T cells are collected by leukapheresis, lentivirally transduced ex vivo to express a CD19-specific chimeric antigen receptor, expanded, and infused after lymphodepleting chemotherapy. Mechanism: CAR engagement of CD19 triggers T-cell activation and cytotoxic killing, producing deep depletion of CD19+ B cells and their precursors to curb autoreactive B-cell activity and autoantibody production. Targets: CD19 antigen, B cells and their precursors, humoral autoimmune pathways in SLE, systemic sclerosis, dermatomyositis, and polymyositis.