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 being Descartes-08 [6] - The company is also developing Descartes-15, a next-generation mRNA CAR-T therapy [6] Product Details - Descartes-08 is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen (BCMA) for generalized myasthenia gravis and systemic lupus erythematosus [5] - The therapy does not require preconditioning chemotherapy and can be administered in an outpatient setting, reducing risks associated with conventional therapies [5] Clinical Trial Information - The Phase 3 AURORA trial will involve approximately 100 participants with acetylcholine receptor autoantibody positive MG, comparing Descartes-08 to a placebo with a primary endpoint focused on improvement in MG-ADL scores [2][3] - The trial is set to commence in the first half of 2025 [1][2] Previous Trial Results - Positive results from the Phase 2b trial showed an average MG-ADL reduction of 5.5 points at Month 4 for participants treated with Descartes-08, indicating deep and durable improvements [3]
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis