Field noteOct 25, 20261 min read1 source

CU Anschutz: one-year KYSA-8 data show single-dose miv-cel CAR-T gains in stiff person syndrome persist

In one minute

University of Colorado Anschutz reported one-year results from KYSA-8, a Kyverna Therapeutics-sponsored phase 2 registrational study of mivocabtagene autoleucel (miv-cel) for stiff person syndrome.

What changed: Adds one-year KYSA-8 results for miv-cel, including persistent mobility and disability improvements and 92% of patients remaining free of ongoing immunotherapy.

All 26 treated patients completed the one-year follow-up after a single dose.

Participants completed a 25-foot walk test in a median 49% less time than before treatment. Of 12 patients who had needed a walking aid for the test, eight no longer needed one at one year. Nine of 26 patients, or 35%, completed the test in under five seconds; 24 of 26, or 92%, remained off ongoing immunotherapy. The release says targeted immune cells had begun returning in 65% of patients while clinical improvements persisted.

The findings were presented at MSToronto26 on October 21, 2026. Kyverna said it intends to complete a rolling Biologics License Application submission in the fourth quarter of 2026. The release does not establish comparative efficacy against another treatment, long-term safety, FDA approval, or outcomes beyond the reported cohort and one-year follow-up.

Evidence / sources

  1. 1news.cuanschutz.edu/news-stories/car-t-cell-therapy-shows-lasting-improvements-in-stiff-person-syndrome-cu-anschutz-led-study-finds
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