eligibility_summary
Inclusion: Adults 18–64, consent/compliant, contraception, 2‑dose COVID‑19 vaccine ≤6 mo. SLE (Abs+, active BILAG), diffuse SSc with rapid progression, DM/PM (weakness, MSA+, active), or AAV (PR3/MPO‑ANCA, active). All with inadequate response to prior therapy. Exclusion: cytopenias, eGFR<30, advanced ILD, active serious infections incl. HIV/HBV/HCV/COVID/TB, pregnancy, recent malignancy, prior CAR‑T, investigational or T/B‑cell drugs, severe CNS SLE, overlap/MCTD.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-CAR_Lenti—an autologous anti-CD19 chimeric antigen receptor T-cell therapy (adoptive cellular immunotherapy/ATMP) made by SIN lentiviral transduction of CD4/CD8 T cells, single IV dose (1×10^6/kg). Mechanism of action: CAR-mediated recognition and cytotoxic clearance of CD19+ B-lineage cells, including activated B cells and plasmablasts, to dampen B-cell–driven autoimmunity by reducing autoantibody production and inflammatory signaling. Cells/pathways targeted: CD19-expressing B cells and plasmablasts, B-cell activation and autoantibody-generation pathways central to SLE, systemic sclerosis, dermatomyositis/polymyositis, and ANCA-associated vasculitis. Trial: open-label, phase I basket (n=8) assessing safety/feasibility and preliminary efficacy, key outcomes include CRS/ICANS, infections, B-cell depletion duration, CAR T persistence, autoantibody changes, and 24-week response.