eligibility_summary
Inclusion: SPS with limb/axial rigidity, continuous co-contraction, spasms from noise/touch/emotion, no other neuro cause, high-titer anti-GAD65 or anti-glycine antibodies (CSF or prior high titer OK). Active despite ≥1 immunotherapy, stiffness index ≥2, most ambulatory. Exclusion: bedridden >3 mo, CNS/spinal tumors, metabolic/infectious myelopathy, inherited/progressive CNS disease incl sarcoidosis/PML, stroke, seizure, dementia, Parkinson’s, cerebellar disease, psychosis, aphasia, EF ≤40%.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
KYSA-8 (NCT06588491) tests KYV-101, an autologous, fully human anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, given after standard lymphodepletion (fludarabine, a purine-analog antimetabolite, cyclophosphamide, an alkylating agent). Mechanism: engineered T cells recognize CD19 and kill B-lineage cells, depleting autoreactive B cells/plasmablasts to reduce pathogenic autoantibodies (anti-GAD65, anti-glycine) and dampen B-cell antigen presentation, cytokine release, and complement activation. Cells/pathways targeted: CD19+ B cells and the humoral autoimmune axis in SPS, indirectly normalizes the GAD–GABA pathway by removing antibody producers. Lymphodepletion facilitates CAR-T expansion/persistence.