Clinical TrialApr 21, 2026, 06:47 PM
Kyverna's miv-cel shows positive registrational trial results in SPS
AI Summary
Kyverna Therapeutics announced positive primary analysis results from its registrational KYSA-8 trial of miv-cel in stiff person syndrome (SPS). A single dose of miv-cel delivered rapid, statistically significant, and clinically meaningful improvements across all primary and secondary endpoints at 16 weeks, with most patients regaining function and all discontinuing chronic immunotherapies. The company believes miv-cel could redefine the treatment paradigm for SPS and is preparing its BLA submission.
Key Highlights
- Single dose of miv-cel achieved rapid, statistically significant improvements across all primary and secondary endpoints at 16 weeks.
- Majority of patients regained function and all patients discontinued chronic immunotherapies.
- Median follow-up was 6.5 months after miv-cel infusion (range, 4.4-12.2 months).
- 26 patients with inadequate response to off-label treatments received 1x10^8 miv-cel CAR T cells.
- Company is preparing BLA submission for miv-cel in stiff person syndrome.