First Patient Dosed in Phase 2 Trial of Descartes-08 for Lupus, Cartesian Therapeutics Announces

GAITHERSBURG, Md., July 2, 2024 — Cartesian Therapeutics, Inc., a clinical-stage biotech firm pioneering mRNA cell therapy for autoimmune diseases, has commenced dosing in its Phase 2 clinical trial of Descartes-08 for patients suffering from systemic lupus erythematosus (SLE).

Descartes-08 stands as Cartesian’s leading mRNA cell therapy candidate and represents a potentially groundbreaking mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T). This autologous mRNA CAR-T product specifically targets B-cell maturation antigen (BCMA). Unlike traditional DNA-based CAR-T therapies, mRNA CAR-T aims to circumvent the need for preconditioning chemotherapy and is designed to minimize the risk of cancerous transformation due to genomic integration.

Previously, Descartes-08 was administered in a Phase 2 trial targeting myasthenia gravis (MG). The safety data from the MG trial has shown promising results, supporting its use in outpatient settings with minimal observation required.

Despite recent advancements in SLE treatments, many patients continue to experience severe symptoms and disease progression. Carsten Brunn, Ph.D., President and CEO of Cartesian, emphasized that Descartes-08 aims to address the limitations of conventional, high-cost DNA-engineered CAR-T therapies. Brunn expressed optimism that Descartes-08 could emerge as a safe and effective outpatient option for SLE patients who do not respond adequately to current treatments.

Dr. Susan Manzi, Chair of the Medicine Institute at Allegheny Health Network and Medical Director for the Lupus Foundation of America, commented on the significance of dosing the first patient with this novel therapy. She highlighted that the current treatment options for lupus are inadequate and expressed hope that Descartes-08, administered as an outpatient therapy, would demonstrate significant and lasting benefits for patients with B cell-mediated autoimmune diseases like lupus.

The open-label Phase 2 trial (NCT06038474) aims to enroll up to 30 adult patients. It will assess the safety and tolerability of administering Descartes-08 without preconditioning chemotherapy in patients with moderate to severe SLE who are refractory to immunosuppressant therapy. Secondary outcomes will measure overall disease activity.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, incurable autoimmune disease characterized by systemic inflammation affecting various organ systems such as the skin, joints, kidneys, brain, and heart. Symptoms can range from mild to potentially life-threatening and often include fatigue, joint pain, rash, and fever. SLE impacts approximately 1.5 million people in the United States.

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage company at the forefront of developing mRNA cell therapies for autoimmune diseases. Its lead asset, Descartes-08, is a first-in-class mRNA CAR-T therapy currently in Phase 2b development for generalized myasthenia gravis and in Phase 2 for systemic lupus erythematosus. A Phase 2 basket trial is also planned to explore additional autoimmune indications. The company’s pipeline includes Descartes-15, a next-generation autologous anti-BCMA mRNA CAR-T.

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