Cartesian Therapeutics reports positive updated Phase 2b results in myasthenia

Cartesian Therapeutics (RNAC) announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis – MG – and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented at the 2nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia. Descartes-08 was previously granted Regenerative Medicine Advanced Therapy Designation and Orphan Drug Designation by the FDA for the treatment of MG. The Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo administered as six weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive MG. Cartesian expects to commence the trial in the first half of 2025. The Phase 2b trial met its primary endpoint and demonstrated a safety profile supporting outpatient administration of Descartes-08. Descartes-08 continues to be observed as well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy. There were no cases of cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome. The Phase 3 AURORA trial on track to commence in 1H2025. Descartes-08-treated participants were observed to have a 5.5-point reduction in MG-ADL at Month 4. Durable responses were observed through Month 12 in Phase 2b trial.