GlobeNewswire·Nov 9, 2026, 11:00 AM ET

Kyverna Therapeutics Announces Publication of Registrational Miv-cel Data in Patients with Stiff Person Syndrome in JAMA Neurology

Kyverna Therapeutics published primary analysis of registrational trial KYSA-8 in JAMA Neurology, demonstrating miv-cel's potential as the first approved therapy for stiff person syndrome (SPS) & first CAR T-cell therapy for an autoimmune disease.
Primary analysis measured at 16 weeks showed statistically significant improvements across all primary & secondary endpoints, including mobility & disability, with all patients discontinuing chronic immunotherapies.
Of 12 patients requiring walking aid assistance at baseline, 67% no longer needed walking assistance at 16 weeks.
The trial included 26 adult SPS patients who received a single dose of miv-cel, resulting in a consistent & well-tolerated safety profile with no high-grade CRS, ICANS, or IEC-HS cases.
Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy designed to deliver durable, drug-free remission via deep B-cell depletion.
SPS is a rare neurologic autoimmune disease with no current FDA-approved treatments, affecting an estimated 6,000 patients in the U.S. & often leading to permanent disability.
Miv-cel has received three FDA Regenerative Medicine Advanced Therapy (RMAT) designations for SPS, generalized myasthenia gravis, & non-active secondary progressive multiple sclerosis.
The full publication details the nonrandomized clinical trial titled "Mivocabtagene Autoleucel CD19 Chimeric Antigen Receptor T-Cell Therapy in Stiff Person Syndrome."