Cartesian Therapeutics announces FDA agreement for new trial

Phase 3 trial of Descartes-08 in myasthenia gravis to start in 1H25

Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its phase 3 AURORA trial of Descartes-08, an mRNA cell therapy candidate for myasthenia gravis (MG).

This approval means the FDA has deemed the trial design acceptable to support a future Biologics License Application for Descartes-08 in MG, contingent on trial outcomes.

“This SPA agreement marks an important milestone,” said Carsten Brunn, PhD, President and CEO of Cartesian: “It provides critical regulatory clarity and a clear path toward potential approval.”

The phase 3 AURORA trial will assess Descartes-08 versus placebo with a 1:1 randomisation. The treatment involves six once-weekly infusions without preconditioning chemotherapy in 100 participants with acetylcholine receptor autoantibody positive MG.

The primary endpoint is the proportion of Descartes-08 participants showing a three-point or more improvement in MG-ADL score at month 4 compared to placebo.

In December 2024, Cartesian announced positive results from the phase 2b trial, demonstrating deep and durable improvements in MG patients.

Dr Brunn noted: “Supported by compelling phase 2b results, we believe Descartes-08 has the potential to serve as a meaningful new therapy without the need for preconditioning chemotherapy.”

Myasthenia gravis is a chronic autoimmune disorder that causes muscle weakness and fatigue, often requiring chronic immunosuppressive medicines.

Descartes-08 is designed to target B-cell maturation antigen and is in clinical development for MG and systemic lupus erythematosus. Dr Brunn added: “We look forward to commencing the phase 3 AURORA trial in the first half of this year.”