eligibility_summary
Include: R/R autoimmune disease lacking effective therapy (e.g., SLE, myositis, SSc, IgG4-RD, pSS, RA, ILD, ITP, PBC) and histologic small‑duct cholangitis, survival ≥3 mo, adequate renal/hepatic/cardiopulmonary function, consent. Exclude: recent cancers, HBV/HCV/HIV/syphilis, major cardiac/systemic disease, active infection, pregnancy/plan ≤2 y, prior CAR‑T, recent trial/live vaccine, CNS involvement, depression/suicidality, other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: UTAA09 injection, a gene‑modified cellular immunotherapy consisting of CD19‑CAR‑engineered γδ T cells (biological). Dosing: IV infusion of 1×10^8–1×10^9 cells, single‑arm, open‑label early study in relapsed/refractory autoimmune diseases (e.g., SLE, idiopathic inflammatory myopathies, systemic sclerosis, IgG4‑RD, primary Sjögren). Mechanism of action: The CAR confers specificity for CD19, triggering γδ T‑cell activation and cytotoxicity (perforin/granzyme and inflammatory cytokines) upon binding, resulting in depletion of CD19+ B‑lineage cells. Targeted cells/pathways: CD19+ naïve, memory B cells and plasmablasts, thereby suppressing B‑cell–driven autoimmunity, reducing autoantibody production, antigen presentation, and germinal center activity. Primary focus: safety, also PK/PD and immunogenicity.