Assessing CAR-T Miv-Cel in Myasthenia Gravis: Srikanth Muppidi, MD

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“…I'm optimistic for the field that CAR-T certainly offers a new paradigm of how we would treat refractory antibody-mediated diseases. In many ways, neurology is at the forefront of this development, and I'm excited for the field, for the faculty, and for the patients who are involved in these trials.”

At the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18 to 22 in Chicago, Illinois, Srikanth Muppidi, MD, clinical professor of adult neurology at Stanford University, reported findings from the phase 2 KYSA-6 clinical trial (NCT06193889) evaluating mivocabtagene autoleucel (miv-cel; KYV-101), an investigational fully human antiCD19 chimeric antigen receptor T-cell (CAR-T) therapy, in patients with myasthenia gravis (MG). NeurologyLive® interviewed Muppidi at the conference to learn more.

Muppidi explained that among 7 patients who received a single dose of miv-cel in the study, robust improvements in clinical symptoms were observed alongside reductions in MG-Activities of Daily Living (MG-ADL) scores. The therapy was well tolerated in the cohort, with low-grade cytokine release syndrome (CRS) observed, but no high-grade CRS or immune effector cell–associated neurotoxicity syndrome events reported. Muppidi also highlighted mechanistic findings from the phase 2 dataset, including CAR T-cell expansion, B-cell depletion, and reductions in pathogenic autoantibody levels. Notably, protective antibody responses—including those against viral infections and vaccination antigens—appeared to remain intact, raising the possibility that the therapy may facilitate an immune reset. He acknowledged that this hypothesis requires further investigation and replication.

With regard to unanswered questions, Muppidi identified durability of response as the most pressing unknown, expressing cautious optimism that benefit may be sustained for at least 1 to 2 years, if not longer. He also noted the absence of comparative data across different CAR-T targets currently under investigation in autoimmune disease, as well as the need for long-term safety follow-up given the recency of this therapeutic approach in nononcologic indications. Looking ahead, Muppidi described plans for a phase 3 randomized trial of miv-cel in MG in which patients will be assigned to miv-cel or continued standard of care, with the option to cross over to miv-cel after 6 months.