Cartesian Therapeutics receives FDA SPA agreement for Phase 3 AURORA trial of Descartes-08 in MG

Cartesian Therapeutics, Inc.

FDA agrees under Special Protocol Assessment that Phase 3 AURORA trial design can support future BLA for Descartes-08 in myasthenia gravis.
Phase 3 trial expected to start in first half of 2025; randomized, placebo-controlled, 100 AChR Ab+ participants.
Primary endpoint: proportion with ≥3-point MG-ADL improvement at Month 4 vs placebo; 1:1 randomization.
Phase 2b data showed average MG-ADL reduction of 5.5 (±1.1) at Month 4 (n=12); well-tolerated without preconditioning chemo.
SPA provides regulatory clarity and a clear path toward potential approval of Descartes-08.

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