FREDERICK, Md. — September 29, 2026
Cartesian Therapeutics announced additional retreatment data from its Phase 2 program evaluating Descartes-08, an investigational autologous anti-BCMA CAR-T therapy, in patients with generalized myasthenia gravis (MG). The case series of five retreated patients presented at the 2026 AANEM Annual Meeting showed sustained improvements in disease severity measures following a second six-weekly-infusion treatment course. Patients were retreated at a median of 16.6 months after completing their initial Descartes-08 treatment, following recurrence of MG symptoms. At Month 12 after retreatment, the mean MG-ADL score had decreased by 6.6 points, while the mean Myasthenia Gravis Composite score decreased by 15 points. Cartesian reported no new safety signals, with topline results from the Phase 3 AURORA trial expected in the first quarter of 2027.
Retreatment Maintains Clinical Improvements Through 12 Months
The retreatment analysis included five patients who experienced recurrence of MG symptoms after at least 12 months of follow-up following their initial Descartes-08 course. Each patient received six once-weekly infusions during retreatment, with efficacy assessed using MG-ADL and Myasthenia Gravis Composite scores. At Month 12, patients had an average 6.6-point reduction in MG-ADL from retreatment baseline, with a standard deviation of 4.2 points, and an average 15-point reduction in MGC scores, with a standard deviation of 6.2 points. All five patients achieved clinically meaningful reductions in MGC, defined as at least three points, and MG-ADL, defined as at least two points. Four patients maintained the clinically meaningful MG-ADL improvement through Month 12. The participants had a mean disease duration of 13 years and extensive prior treatment histories.
Descartes-08 Retreatment Shows No New Safety Signals
Cartesian reported that the safety profile following retreatment remained consistent with previously reported findings, with adverse events described as transient and mild. No serious adverse events were reported during the retreatment period, and the company said Descartes-08 was generally well tolerated through Month 12. Notably, there were no reported cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, cytopenias or hypogammaglobulinemia during retreatment. Descartes-08 is being developed as an autologous CAR-T therapy targeting B-cell maturation antigen (BCMA), with the company’s manufacturing and administration approach designed to avoid lymphodepleting chemotherapy and allow outpatient treatment. The retreatment data are based on a small five-patient case series and therefore require confirmation in larger controlled clinical studies.
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Phase 3 AURORA Readout Expected in Early 2027
Cartesian is advancing Descartes-08 into Phase 3 development through the AURORA trial, with topline results expected in the first quarter of 2027 and a potential BLA filing planned for mid-2027. The FDA has granted Descartes-08 Regenerative Medicine Advanced Therapy and Orphan Drug designations for MG, and Cartesian has received written FDA agreement under the Special Protocol Assessment process regarding the overall Phase 3 trial design. Descartes-08 is also being evaluated in Phase 2 studies in myositis, including dermatomyositis and antisynthetase syndrome, as well as Phase 1/2 development in pediatric autoimmune diseases. The candidate remains investigational, and the retreatment findings do not establish long-term efficacy or comparative benefit. The ongoing Phase 3 AURORA study is expected to provide the larger-scale evidence needed to assess the safety and efficacy of Descartes-08 in generalized MG.
Source :Cartesian Therapeutics press release
