eligibility_summary
Include: R/R autoimmune disease after failed standard therapy with biopsy‑proven non‑suppurative small‑duct cholangitis, survival ≥3 mo, Cr ≤1.5×ULN, TBil ≤2× (≤3× if Gilbert), ALT/AST ≤2.5× (≤5× if disease), no severe mental illness, consent. Exclude: recent malignancy, HBV/HCV/HIV/syphilis, serious cardiac/unstable systemic disease, active infection, pregnant/lactating or pregnancy planned ≤2 yrs, prior CAR‑T/gene‑cell therapy, trial <1 mo, CNS disease, suicidality, per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: open-label, single-arm Phase 1/2 in relapsed/refractory autoimmune diseases (e.g., SLE, Sjögren’s). Intervention: autologous BCMA and/or CD19 CAR-T cells (genetically modified T-cell therapy) infused after lymphodepletion with fludarabine (purine analog inhibiting lymphocyte DNA synthesis) and cyclophosphamide (alkylating agent) to promote CAR-T expansion, repeat doses may be given. Mechanism: CAR-T cells bearing anti-BCMA or anti-CD19 receptors recognize and kill target cells via T-cell activation and cytotoxicity. Targets/cell pathways: CD19+ B-lineage cells (naive, memory, some plasmablasts) to ablate autoreactive B cells and antigen presentation, BCMA (TNFRSF17)+ long-lived plasmablasts/plasma cells to disrupt BAFF/APRIL-mediated survival and autoantibody production, aiming to reset B-cell immunity and reduce pathogenic antibodies. Primary focus: safety and persistence.