Cartesian Therapeutics Announces Positive Retreatment Data for Descartes-08

FREDERICK, Md., Sept. 29, 2026 /CourierPR/ -- Cartesian Therapeutics, a late clinical-stage biotechnology company, has announced additional positive retreatment data for its lead investigational asset, Descartes-08, in patients with generalized myasthenia gravis (MG). The data, presented during the Scientific Session of the 2026 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting, highlights sustained symptom improvement and deep, durable responses in patients who have experienced a recurrence of MG symptoms at least 12 months after their initial treatment course.

The retreatment data, which analyzed five patients who had previously received a full treatment course in the Phase 2 portion of the trial, demonstrated that these patients experienced greater improvement in MG symptoms compared to their initial course of treatment. Specifically, the mean decrease in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores was sustained through 12 months following retreatment. The retreatment consisted of six once-weekly Descartes-08 infusions, similar to the initial course.

At Month 12 following the retreatment, the patients observed an average MG-ADL reduction of 6.6 (±4.2) points from baseline. Additionally, the average Myasthenia Gravis Composite (MGC) reduction was 15 (±6.2) points from baseline. All five patients experienced a clinically meaningful reduction across MGC (≥3-point reduction) and MG-ADL scores (≥2-point reduction), with four patients maintaining the clinically meaningful MG-ADL reduction through Month 12 following retreatment.

The safety profile of Descartes-08 was consistent with previously reported data. No new safety signals were reported, and the therapy was generally well-tolerated through Month 12 following retreatment. Adverse events were transient and mild, with no serious adverse events reported during retreatment. Notably, there were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenias, or hypogammaglobulinemia.

Cartesian Therapeutics, Inc. (NASDAQ: RNAC) continues to advance its development of Descartes-08, a BCMA-targeted autologous CAR-T cell therapy for MG and myositis. The company has previously received Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG. Cartesian also received a written agreement from the FDA under the Special Protocol Assessment (SPA) process, indicating the overall design of the planned Phase 3 AURORA trial of Descartes-08 is acceptable to support a future biologics license application (BLA) in MG, subject to the ultimate outcome of the trial.

The company remains on track to read out topline data from its Phase 3 AURORA trial of Descartes-08 in MG in the first quarter of 2027, with a BLA filing expected in mid-2027. Descartes-08 is being developed with the goal of providing sustained clinical benefit following a finite course of treatment, unlike currently approved therapies that generally require cyclical dosing to maintain effect. The therapy is designed to target BCMA+ immune cells in MG to potentially provide patients with sustained symptom improvement, the ability to be re-dosed if symptoms recur, and the quality-of-life benefits of outpatient administration without lymphodepleting chemotherapy.

The data from the retreatment analysis strengthen Cartesian Therapeutics' conviction in Descartes-08 as it approaches the topline results from the Phase 3 AURORA trial. The company's lead asset, Descartes-08, is in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis.