Cartesian announces positive results from Phase IIb myasthenia gravis trial

Cartesian Therapeutics has declared positive results from its Phase IIb trial of Descartes-08, an autologous mRNA-engineered CAR-T therapy, in generalized myasthenia gravis (MG) patients. The study, a double-blind, crossover, placebo-controlled trial involving 36 heavily treated MG patients, administered Descartes-08 or placebo as six weekly outpatient infusions without preconditioning chemotherapy. After a three-month blinded follow-up, placebo recipients had the option to switch to Descartes-08.

The primary endpoint was achieving a five-point or greater reduction in the MG Composite (MGC) score. Descartes-08 met this endpoint significantly, with 71% of patients seeing improvements compared to 25% with placebo. Similar positive outcomes were seen in the per-protocol population, with substantial improvements across MG severity scales at follow-ups in months four and six.

Descartes-08 demonstrated a favorable safety profile, with transient and mild adverse events. These findings support Descartes-08 as a promising treatment option for MG, pending further validation in larger trials.