Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Cartesian announces positive results from Phase IIb myasthenia gravis trial

Cartesian Therapeutics has reported promising findings from its Phase IIb trial evaluating Descartes-08, an autologous mRNA-engineered CAR-T cell therapy, in generalized myasthenia gravis (MG) patients. The double-blind, crossover, placebo-controlled trial included 36 heavily treated MG patients.

Participants were randomized 1:1 to receive either Descartes-08 or placebo through six weekly outpatient infusions without preconditioning chemotherapy. The primary efficacy endpoint, achieving a reduction of five points or more in the MG Composite (MGC) score, was met with statistical significance. 71% of Descartes-08 recipients versus 25% of placebo recipients achieved this improvement at month three. 

Patients treated with Descartes-08 showed significant improvements across various MG severity scales at months three, four, and six, with a favorable safety profile and mostly mild, transient adverse events reported.

These results highlight Descartes-08's potential as a therapeutic option for MG and warrant further clinical development.