Naji Gehchan, MD, MBA, on Evaluating CAR-T KYV-101 for Generalized Myasthenia Gravis

“As a physician, and certainly as a treating physician, the ultimate goal is freeing patients from their chronic disease—freeing them from the therapies they need to take chronically. Being able today with a single dose of KYV-101 to achieve those results, a durable drug-free, disease-free remission, is really a change of paradigm of how you treat MG.”

Generalized myasthenia gravis (gMG), like many autoimmune diseases, remains difficult to treat with currently available options. As such, substantial unmet need remains for patients and innovation is ongoing. Among the investigational modalities currently being explored to address the condition is chimeric antigen receptor T-cell (CAR-T) therapy.

Notably, at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held October 29 to November 1, in San Francisco, California, Kyverna Therapeutics presented updated data from its phase 2/3 KYSA-6 clinical trial (NCT06193889), which is evaluating investigational CD19-directed CAR-T therapy KYV-101 for the treatment of gMG. The data specifically pertained to the 6 patients who had been treated in the phase 2 portion as of an October 3, 2025, data cutoff.

CGTLive® sat down with Naji Gehchan, MD, MBA, the chief medical and development officer of Kyverna, to learn more about the key results and their implications. Gehchan highlighted "profound” improvements in Myasthenia Gravis Activities of Daily Living and Quantitative Myasthenia Gravis scores observed as early as 2 weeks and lasting up to 36 weeks after a single infusion. Importantly, 100% of patients responded to treatment, and two-thirds achieved minimal symptom expression—outcomes not seen with currently available therapies. Gehchan also highlighted a tolerable safety profile, with only low-grade cytokine release syndrome and no immune-effector-cell-associated-neurotoxicity-syndrome (ICANS). He also noted that all patients were able to discontinue immunosuppressive medications, with 5 of 6 remaining free of immunosuppressants at their latest follow-up. He described the findings as a paradigm shift in gMG treatment, offering the potential for durable, drug-free remission.

REFERENCE
1. Kyverna Therapeutics announces positive interim phase 2 data from KYSA-6 study of KYV-101 in generalized myasthenia gravis at AANEM 2025. News release.Kyverna Therapeutics, Inc. October 29, 2025. Accessed October 30, 2025. https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-positive-interim-phase-2-data