eligibility_summary
Include: R/R autoimmune disease after failed standard therapy, survival ≥3 mo, adequate organs (Cr ≤1.5×ULN, acceptable ECG, SpO2 >91%, TBil ≤2×ULN [≤3× if Gilbert, direct ≤1.5×], ALT/AST ≤2.5× [≤5× if disease‑related]), consent. Exclude: other malignancy ≤5 y, HBV/HCV/HIV/syphilis positive, major cardiac or unstable systemic disease, active infection ≤7 d, pregnant/lactating or planning ≤2 y, prior CAR‑T/gene‑modified cells, other trial ≤1 mo, CNS involvement, live vaccine ≤28 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: UTAA09 injection—CD19-directed chimeric antigen receptor gamma-delta T cells (CD19-CAR-γδ T), a gene-modified cellular immunotherapy (biological). Mechanism of action: Engineered γδ T cells express an anti-CD19 CAR that binds CD19 on B-lineage cells, triggering T-cell activation and cytotoxic killing (perforin/granzyme), leading to broad depletion of pathogenic B cells and plasmablasts, reduction of autoantibody production, and modulation of antigen presentation and inflammatory cytokine signaling. γδ T cells act in an MHC-independent manner and provide innate-like cytotoxicity, the CAR redirects this activity to CD19. Targets/cells/pathways: CD19+ B cells (naïve, memory, plasmablasts), humoral autoimmunity pathways (autoantibody generation, BCR-driven and germinal center responses), B cell–T cell costimulation and downstream inflammatory cytokine networks. Study: single-arm, open-label, early-phase trial, IV dosing ~1×10^8–1×10^9 cells.