eligibility_summary
Adults 18–65 with CD19+ B cells, adequate marrow/liver/renal/coagulation and stable cardiac function, contraception/negative HCG, consent. Include refractory/relapsing SLE, Sjögren’s, diffuse systemic sclerosis, inflammatory myopathy, ANCA‑vasculitis, or antiphospholipid syndrome per standard criteria with required antibodies/activity scores. Exclude severe allergy, uncontrolled infection, CNS/cardiac disease, Ig deficiency, recent cancer, ESRD, active HBV/HCV/HIV/syphilis, psych/cognitive illness, recent trials/immunosuppressants, pregnancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06379646 (recruiting). Intervention: YTS109 cell injection, a gene‑modified T‑cell therapy (engineered cytotoxic T cells, single infusion ~3×10^6 cells/kg). Mechanism of action: CD19‑directed T cells recognize and kill CD19+ B cells, aiming to deplete autoreactive B‑cell populations, reduce autoantibody production, and “reset” humoral immunity. Drug type: Cell-based immunotherapy (engineered anti‑CD19 T cells, CAR/STAR‑like design). Target cells/pathways: CD19+ B cells and their precursors/plasmablasts, downstream effects on autoantibody/immune complex pathways and B‑cell–driven antigen presentation and cytokine signaling. Indications: refractory/recurrent autoimmune diseases (SLE, systemic sclerosis, inflammatory myopathy, ANCA‑associated vasculitis, antiphospholipid syndrome, Sjögren’s). Primary focus: safety, early efficacy, and PK/PD (B‑cell depletion and immune modulation).