Naji Gehchan, MD, MBA, Chief Medical and Development Officer at Kyverna Therapeutics, discusses new follow-up data on KYV-101 treatment for patients with myasthenia gravis (MG).
Generalized MG (gMG) is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. The condition results from a defect in the transmission of nerve impulses to muscles due to the presence of antibodies against the acetylcholine receptor. The exact reason this occurs is not known.
An update of KYSA-6 (NCT06193889) a phase 2, open-label, single-arm, multicenter study of KYV-101 in gMG was presented at the 2026 American Academy of Neurology Annual Meeting. KYV-101 is a fully human, autologous CD19 CAR T-cell therapy with CD28 costimulation, designed to achieve deep B-cell depletion and immune reset to deliver durable, drug-free, disease-free remission.
In the study, adults ages 18 to 75 years with gMG (MGFA class IIb-IV), history of AChR or MuSK autoantibodies, MG Activities of Daily Living (MG-ADL) score of 6 or greater, and 2 or more immunosuppressant/immunomodulator failures, received lymphodepletion and a single infusion of 1×10^8 CAR T cells.
As of October 2025, 6 patients were dosed and follow-up ranged from 28 days to 9 months. Robust CAR T-cell expansion and B-cell depletion occurred in all patients. With a single dose, 100% of patients had 3-point or greater improvements in MG-ADL from baseline, with 50% achieving minimal symptom expression at last follow-up. At 24 weeks, KYV-101 treatment resulted in 8.0-point and 7.7-point mean reductions from baseline in MG-ADL and QMG scores, respectively. Of the 6 patients, 5 became nonsteroidal immunosuppressant therapy-free. No ICANS and no high-grade CRS events occurred.
Overall, treatment with KYV-101 resulted in robust and sustained improvements in disease severity with an acceptable safety profile, while eliminating background immunosuppressants in the majority of patients. A phase 3 clinical study is ongoing.
To learn more about gMG and other rare neurological conditions, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/
