Core Viewpoint - Cartesian Therapeutics has received FDA agreement on the Phase 3 AURORA trial design for its mRNA cell therapy candidate Descartes-08, aimed at treating myasthenia gravis (MG), indicating a clear path toward potential approval [1][2] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on mRNA cell therapy for autoimmune diseases, with its lead asset Descartes-08 in development for generalized myasthenia gravis and systemic lupus erythematosus [6] Trial Details - The Phase 3 AURORA trial will be a randomized, double-blind, placebo-controlled study involving approximately 100 participants with acetylcholine receptor autoantibody positive MG, assessing the efficacy of Descartes-08 compared to placebo [2][3] - The primary endpoint of the trial is to evaluate the proportion of participants showing a three-point or greater improvement in the MG Activities of Daily Living (MG-ADL) score at Month 4 [2] Previous Results - Positive results from the Phase 2b trial indicated that participants treated with Descartes-08 experienced an average MG-ADL reduction of 5.5 (±1.1) at Month 4, demonstrating deep and durable improvements [3] Treatment Characteristics - Descartes-08 is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy that does not require preconditioning chemotherapy and can be administered in an outpatient setting, reducing risks associated with conventional therapies [5] - The therapy has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for treating MG [5] Disease Context - Myasthenia gravis is a chronic autoimmune disorder characterized by muscle weakness and fatigue, with no current cure available, necessitating chronic immunosuppressive treatments that carry risks and side effects [4]
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis