Kyverna Therapeutics reported positive Phase II data for KYV‑101, a fully human, autologous CD19 CAR‑T with CD28 co‑stimulation, in generalized myasthenia gravis (gMG). In the Phase II portion of the registrational KYSA‑6 trial the company said a small cohort achieved clinically meaningful improvements across MG‑ADL and QMG endpoints; several patients reached minimal symptom expression by Week 24. All six participants experienced cytokine release syndrome, mostly Grade 1–2. Kyverna plans to start Phase III work by year‑end, citing the interim results as supportive of a registrational pathway. Independent clinicians raised caveats about small cohort size and cross‑trial comparisons but called the magnitude of response notable. The results spotlight CAR‑T approaches extending beyond oncology into autoimmune disease. If Kyverna’s larger trials confirm durability and manageable safety, KYV‑101 could become a single‑dose alternative to chronic immunosuppression for refractory gMG.
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