Cartesian Therapeutics, a clinical-stage biotechnology company, is making strides in the development of mRNA cell therapies for autoimmune diseases. The company highlighted its progress and strategic priorities for 2025, focusing on its lead candidate, Descartes-08, and its next-generation therapy, Descartes-15.
Descartes-08 for Myasthenia Gravis
The Phase 3 AURORA trial of Descartes-08 for myasthenia gravis (MG) is on track to commence in the first half of 2025. This randomized, double-blind, placebo-controlled trial will assess Descartes-08 versus placebo in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. Participants will receive six once-weekly infusions without preconditioning chemotherapy. The primary endpoint will measure the proportion of Descartes-08 participants with an improvement in MG-ADL score of three points or more at Month 4 compared to placebo.
Updated results from the Phase 2b trial of Descartes-08 in MG patients demonstrated deepening responses over time. Participants in the primary efficacy dataset (n=12) experienced an average MG Activities of Daily Living (MG-ADL) reduction of 5.5 (±1.1) at Month 4. The therapy was well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy.
Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian, stated, "We recently shared updated Phase 2b results which continue to support the potential for Descartes-08 to provide deep and durable improvements for patients with MG in the convenient outpatient setting without the need for preconditioning chemotherapy."
Expanding Descartes-08 to Systemic Lupus Erythematosus and Juvenile Dermatomyositis
Enrollment is ongoing in a Phase 2 open-label trial evaluating Descartes-08 in systemic lupus erythematosus (SLE). The trial is assessing the safety, tolerability, and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in SLE patients. A data readout is expected in the second half of 2025. SLE is an incurable autoimmune disease affecting approximately 1.5 million people in the United States.
Cartesian also plans to commence a Phase 2 basket trial of Descartes-08 in pediatric patients with select autoimmune diseases, including juvenile dermatomyositis (JDM), in 2025. The FDA has granted Rare Pediatric Disease Designation to Descartes-08 for JDM.
Descartes-15: Next-Generation Anti-BCMA CAR-T Therapy
Dosing is underway in a Phase 1 clinical trial of Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T cell therapy. The Phase 1 dose escalation trial is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 trial, Cartesian plans to assess Descartes-15 in autoimmune indications.
Preclinical studies have shown that Descartes-15 achieves an approximately ten-fold increase in CAR expression and selective target-specific killing compared to Descartes-08. Like Descartes-08, Descartes-15 is designed for administration without preconditioning chemotherapy and does not use integrating vectors.
With sufficient cash resources to support planned operations into mid-2027, including the completion of the Phase 3 trial for Descartes-08 in myasthenia gravis, Cartesian Therapeutics is poised to make significant advancements in mRNA cell therapy for autoimmune diseases.
