eligibility_summary
Adults 18–60 with AQP4-IgG+ NMOSD (2015) core features (e.g., optic neuritis or myelitis), relapsing despite steroids+AZA/MMF/RTX, ≥2 relapses/12 mo or ≥3/24 mo (≥1 in past 12 mo), WOCBP: neg test+contraception. Exclude: CNS disease/epilepsy, QT prolongation/serious cardiac, pregnant/lactating, active infection incl HBV/HCV/HIV, recent systemic steroids, poor CD3/CD28 proliferation, renal/hepatic dysfunction, uncontrolled disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous CD19-directed CAR-T cell infusion (adoptive cellular gene therapy, gene‑modified T-cell immunotherapy). Mechanism of action: Patient T cells are engineered to express an anti‑CD19 chimeric antigen receptor, CAR engagement activates T-cell cytotoxicity to eliminate CD19+ B cells and plasmablasts, reducing production of pathogenic AQP4-IgG autoantibodies and dampening humoral autoimmunity. Cells/pathways targeted: CD19-expressing B-cell lineage (naive, memory, plasmablasts), the CD19/BCR signaling axis, downstream effect is reduced AQP4-IgG–mediated complement injury to astrocytes in NMOSD. Trial design: Phase I, single-arm, open-label study in relapsed/refractory AQP4-IgG+ NMOSD, primary endpoints are safety and CAR-T pharmacokinetics.