Kyverna Therapeutics disclosed full registrational trial results for mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome (SPS), strengthening the case for what could become the first approved CAR-T in an autoimmune indication. In KYSA-8, Kyverna reported rapid, statistically significant improvements across primary and secondary endpoints at 16 weeks, with a large share of patients regaining function. The company framed the dataset as a durability and clinical-burden inflection point, reporting that patients reduced or stopped chronic immunotherapies and that the therapy was well tolerated. The results come alongside Kyverna’s plan to submit a biologics license application (BLA) in the first half of the year. Investors and clinicians are watching whether regulators will treat autoimmune CAR-T under existing blood-cancer frameworks or require additional endpoints tied to long-term immune reset and safety monitoring. Kyverna’s next steps could set precedent for the autoimmune CAR-T segment.