eligibility_summary
Eligible: AChR/MuSK Ab+ MG, MGFA II-IV, MG-ADL ≥6 and QMG ≥11, refractory (failed ≥2 IS/IM or ≥1 + chronic IVIG/PLEX >4/yr ≥12 mo), stable background therapy (steroids/IS ≥1 mo, AZA ≥2 mo, AChE-I ≥2 wks), no IVIG/PLEX ≤4 wks (unless SOC), no anti-CD20/19 ≤12 wks, no FcRn ≤4 wks. Exclude: unable to interrupt for apheresis, other NMJ/muscle disease, serious neuro/psych or cardiopulmonary disease, immunodeficiency/transplant/splenectomy, active/recurrent infection, chronic anticoagulation that cannot be held.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
KYSA-6 (NCT06193889) evaluates KYV-101, an autologous, fully human anti-CD19 chimeric antigen receptor T-cell therapy (cellular biologic), versus ongoing standard-of-care immunosuppression in generalized myasthenia gravis. Mechanism: patient T cells are engineered to express a CD19-directed CAR, on engaging CD19 they lyse B cells/plasmablasts, depleting autoreactive and normal B cells in blood and lymphoid/non-lymphoid tissues, thereby reducing anti-AChR/anti-MuSK autoantibodies and suppressing humoral autoimmunity at the neuromuscular junction. Lymphodepletion uses cyclophosphamide (alkylating agent) and fludarabine (purine analog) to reduce endogenous lymphocytes and promote CAR-T expansion. Targets: CD19+ B-lineage cells and autoantibody production pathways. Comparator: standard-of-care immunosuppressive therapy.