Cartesian Therapeutics Receives FDA Agreement for Phase 3 Trial in Myasthenia Gravis

By Tamara Parker • Monday, January 27 10:33 • Permanent Link

Cartesian Therapeutics, Inc. (NASDAQ: RNAC) has announced that it has received a special protocol assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) for the Phase 3 Aurora trial of Descartes-08 in myasthenia gravis (MG). The trial is on track to commence in the first half of 2025.

The randomized, double-blind, placebo-controlled Phase 3 Aurora trial is designed to assess Descartes-08 versus placebo in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG-ADL score of three points or more at month 4 compared to placebo.

In December 2024, Cartesian Therapeutics announced positive updated results from the Phase 2b trial of Descartes-08 in participants with MG. Participants experienced an average MG activities of daily living (MG-ADL) reduction of 5.5 (±1.1) at month 4. Descartes-08 was observed to be well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy.

Descartes-08, Cartesian's lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. It has been granted orphan drug designation and regenerative medicine advanced therapy designation by the FDA for the treatment of MG, and rare pediatric disease designation for the treatment of juvenile dermatomyositis.

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapy for the treatment of autoimmune diseases. Their clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. As a result of these announcements, the company's shares have moved 1.6% on the market, and are now trading at a price of $19.5. For more information, read the company's full 8-K submission here.

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