Trial to assess outpatient administration without lymphodepleting chemotherapy in patients with SLE

GAITHERSBURG, MD, USA I July 02, 2024 I Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in its Phase 2 open-label clinical trial evaluating Descartes-08 in patients with systematic lupus erythematosus (SLE).

Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous mRNA CAR-T product candidate targeting B-cell maturation antigen (BCMA). In contrast to conventional DNA-based CAR-T cell therapies, mRNA CAR-T administration is designed not to require preconditioning chemotherapy and is not expected to carry the risk of genomic integration associated with cancerous transformation.

Descartes-08 has previously been administered in patients in a Phase 2 clinical trial for the treatment of myasthenia gravis (MG). To date, the safety profile from the MG trial supports outpatient administration with minimal observation.

“Despite recent advances in the SLE treatment landscape, many patients receiving currently available therapies continue to experience severe, incapacitating symptoms and disease progression,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Descartes-08 is purposefully designed to overcome the limitations associated with the application of conventional, costly DNA-engineered CAR-T cell therapies for autoimmune diseases. We believe that Descartes-08 could serve as a safe and effective outpatient option for the patients with SLE for whom existing therapies fall short. We are committed to unlocking the full potential of Descartes-08 and look forward to advancing this trial in the months ahead.”

“Dosing of the first patient with Cartesian’s autologous mRNA CAR-T cell therapy is a monumental accomplishment for the lupus patient community,” said Susan Manzi, M.D., M.P.H., Chair of the Medicine Institute at Allegheny Health Network and Medical Director for the Lupus Foundation of America. “Treatment options for lupus patients are suboptimal. I am hopeful that Descartes-08 administered as an outpatient therapy will demonstrate early and long-lasting clinical benefit in patients with certain B cell-mediated autoimmune diseases like lupus.”

The Phase 2 open-label trial (NCT06038474), which is expected to enroll up to 30 adult patients, is designed to evaluate the safety and tolerability of outpatient administration of Descartes-08 without preconditioning chemotherapy for the treatment of patients with moderate or severe SLE refractory to immunosuppressant therapy. Secondary outcome measures will assess overall disease activity.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is an incurable chronic autoimmune disease marked by systemic inflammation that affects multiple organ systems including the skin, joints, kidneys, brain, and heart. The symptoms of SLE can range from mild to 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 pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systematic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. For more information, please visit or follow the Company on LinkedIn or X, formerly known as Twitter.

SOURCE: Cartesian Therapeutics