Pipeline

Cartesian is advancing its pipeline of mRNA cell therapies, which includes multiple clinical assets, for the treatment of autoimmune conditions. Cartesian is also pursuing new ideas in its discovery programs.

Asset Indication Discovery / Preclinical Phase 1 Phase 2 Phase 3
Descartes-08 Autologous mRNA CAR-T
Myasthenia Gravis (MG)
Myositis (Dermatomyositis & Antisynthetase Syndrome)
Juvenile Dermatomyositis

Descartes-08

Descartes-08, Cartesian’s lead candidate, is an mRNA chimeric antigen receptor T-cell cell therapy (mRNA CAR-T) in clinical development for autoimmune disease. CAR-T cell therapy involves modifying a patient’s T cells—key components of the immune system that help identify and attack pathogens—to selectively target and suppress the immune responses that are believed to contribute to their condition.

Descartes-08 is an autologous mRNA CAR-T, which means it uses a patient’s own T cells modified with mRNA to help them better target and fight their disease. More specifically, Descartes-08 targets B-cell maturation antigen (BCMA), a cell surface protein involved in regulating immune responses, to help modulate the overactive immune activity seen in certain autoimmune diseases.

Descartes-08 is designed to be dosed safely in an outpatient setting without pretreatment chemotherapy. In a Phase 2 clinical trial in patients with generalized myasthenia gravis (MG), Descartes-08 was observed to be well tolerated, and adverse events were transient and mostly mild, supporting outpatient administration without the need for pretreatment chemotherapy.

Cartesian is developing Descartes-08 for the treatment of generalized MG and myositis.

Learn More About Generalized
Myasthenia Gravis
Learn More About Myositis
Learn More About Juvenile Dermatomyositis

Cartesian has been awarded several grants related to Descartes-08 from the National Institutes of Health (NIH) and is working with the NIH to advance the development of Descartes-08 through a research partnership. Descartes-08 has been granted Regenerative Medicine Advanced Therapy Designation and Orphan Drug Designation for the treatment of MG, as well as Rare Pediatric Disease Designation for the treatment of JDM, by the U.S. Food and Drug Administration.

These FDA-sponsored designations support Cartesian, offering benefits at different stages throughout clinical development and the potential approval process. For example, receiving RMAT Designation offers sponsor companies the benefits of the fast track and breakthrough therapy designation programs, allowing for early, close, and frequent interactions with the FDA with the goal of expediting drug development.

Myasthenia Gravis

Generalized myasthenia gravis (MG) is a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. It affects over 106,000 people across the U.S. Patients often suffer from visual disturbances such as double vision, along with difficulties in speaking, swallowing, and even breathing. There is currently no cure for MG, and treatment typically requires chronic immunosuppressive medicines, with their attendant risks and side effects.

In a Phase 2b double-blind, placebo-controlled study (NCT04146051), MG participants who received Descartes-08 experienced deep and durable responses over time, with statistically significant and clinically meaningful improvements in symptoms compared to participants who received placebo. Consistent with previously reported results from the Phase 2a open-label portion of the trial, Descartes-08 was observed to be well tolerated, and adverse events were transient and mostly mild, supporting outpatient administration without the need for pretreatment chemotherapy.

Cartesian expects data from its Phase 3 AURORA trial in 1Q27 with BLA planned for mid-2027 (NCT06799247).

Myositis

Myositis is a rare set of pathogenic autoantibody-driven diseases characterized by inflammation and muscle weakness. Myositis symptoms can range from mild to life-threatening and symptoms often include muscle weakness, joint or muscle pain, fatigue, swelling, trouble breathing or swallowing, and arrythmia. Myositis impacts approximately 80,000 people in the United States. With strong mechanistic alignment with existing clinical data in MG and SLE, Cartesian has initiated its Phase 2 TRITON trial in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome (NCT07391605).

Data from a subset of patients is expected in 1H27 to inform path forward to a pivotal trial.

Juvenile Dermatomyositis

Juvenile Dermatomyositis (JDM) is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM.

Cartesian has initiated its Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including JDM and expects data in 1H27 (NCT07089121).