eligibility_summary
Adults (≥18) with active SLE (SLEDAI≥8), SS (ESSDAI≥14), SSc with ILD (mRSS 10–35), DM ≥1 yr with activity criteria and ≥1 myositis‑specific Ab, or ANCA‑AAV (BVAS≥15), ECOG 0–1, adequate organ function, contraception and consent required. Exclude prior CAR‑T, serious comorbidities, active infection, prior transplant/GVHD, positive HBV/HCV/HIV/syphilis/CMV, recent live vaccine, pregnancy, recent cancer (limited exceptions), recent trial, investigator discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-targeted CAR-T cells (autologous, gene‑modified T‑cell immunotherapy, biological). Single IV infusion of patient T cells engineered with a chimeric antigen receptor that binds CD19. Mechanism: CAR engagement activates cytotoxic T cells to eliminate CD19+ B cells/plasmablasts (perforin/granzyme, cytokines), leading to profound B‑cell depletion, reduced autoantibody production, and potential reset of humoral immunity. Targets: CD19-expressing B‑cell lineage (naive/memory B cells, plasmablasts/early plasma cells). Pathways modulated: B‑cell receptor signaling, antigen presentation, and downstream inflammatory cytokine networks driving autoimmunity (relevant to SLE, Sjögren’s, systemic sclerosis, dermatomyositis, and ANCA‑associated vasculitis). Phase 1, single‑arm study.