Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG) [2][4] - Descartes-08 demonstrated sustained symptom improvement with an average reduction of 4.8 points in MG Activities of Daily Living (MG-ADL) at Month 12 [6][8] - The therapy showed particularly strong results in participants without prior exposure to biologic therapies, achieving an average 7.1-point reduction in MG-ADL [10] Efficacy Results - In the Phase 2b trial, participants receiving Descartes-08 experienced deep responses, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12 [6][4] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [6] - Among participants without prior biologic therapy, 100% maintained a clinically meaningful response through Month 12 [10] Safety Profile - Descartes-08 was well-tolerated, with no new adverse events reported during the 12-month follow-up [10] - Common side effects included transient infusion-related reactions such as fever (60%), chills (60%), headache (55%), and nausea (45%), all resolving within 24 hours [10] - No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported [10] Future Developments - The Phase 3 AURORA trial is set to dose the first patient in the second quarter of 2025, following FDA agreement on the trial design [8][10] - Descartes-08 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for the treatment of MG [12][8] - The company aims to transform the treatment landscape for MG with Descartes-08, offering a safe and durable outpatient therapy option [8][10]
Cartesian Therapeutics' Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial