EMERYVILLE, Calif. — October 7, 2026
Kyverna Therapeutics announced that new clinical data for its investigational CD19 CAR T-cell therapy miv-cel will be presented at the MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting in Toronto from October 21–23. The company will present full one-year results from the KYSA-8 registrational Phase 2 trial in stiff person syndrome (SPS), alongside updated Phase 1 investigator-initiated trial data in progressive multiple sclerosis (MS). Kyverna said the SPS results demonstrate sustained clinical benefit following a single dose of miv-cel and a well-tolerated safety profile, with no high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS).
KYSA-8 Data Support Continued SPS Development
The KYSA-8 study is a pivotal, multicenter Phase 2 trial evaluating mivocabtagene autoleucel, formerly known as KYV-101, in patients with stiff person syndrome. SPS is a rare neurologic autoimmune disease characterized by muscle stiffness, painful spasms and progressive impairment of mobility. Kyverna said the upcoming one-year analysis will provide additional evidence on the durability of clinical outcomes after a single administration of miv-cel. The data are scheduled for presentation by Amanda Piquet, M.D., FAAN, of the University of Colorado Anschutz School of Medicine, on October 21. The company is advancing the program toward a planned Biologics License Application (BLA) submission in the fourth quarter of 2026.
Updated Phase 1 Data in Progressive Multiple Sclerosis
An additional oral presentation will provide updated results from a Phase 1 investigator-initiated study evaluating CD19-directed CAR T-cell therapy in progressive multiple sclerosis. Kyverna said the updated findings continue to show encouraging clinical activity together with a well-tolerated safety profile. The company is investigating miv-cel in B-cell-driven autoimmune diseases based on its ability to deeply deplete B cells and potentially reset abnormal immune responses. The progressive MS presentation is scheduled for October 23 and will be delivered by Jeff Dunn, M.D., of Stanford University. Miv-cel has received FDA Regenerative Medicine Advanced Therapy (RMAT) designations for SPS, generalized myasthenia gravis and non-active secondary progressive MS.
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Kyverna Advances Neurologic Autoimmune Pipeline
Miv-cel is a fully human, autologous CD19-targeting CAR T-cell therapy incorporating CD28 costimulation and is being developed as a single-dose treatment for B-cell-driven autoimmune diseases. More than 100 patients have received miv-cel across multiple autoimmune disease programs, according to Kyverna. The company has completed its registrational SPS study and is continuing a registrational program in generalized myasthenia gravis while preparing its regulatory submission for SPS. If approved, Kyverna said miv-cel could become the first CAR T-cell therapy approved for an autoimmune disease and the first approved treatment specifically for SPS. The upcoming conference presentations will provide additional clinical evidence as the company moves its lead program toward regulatory review.
Source::Kyverna Therapeutics, press release
