First Patient Dosed in Cartesian's Phase 2 Descartes-08 Lupus Trial

Cartesian Therapeutics, Inc., a clinical-stage biotechnology company, has initiated a Phase 2 open-label clinical trial to evaluate Descartes-08 in patients suffering from systemic lupus erythematosus (SLE). The first patient has already been dosed in this trial. Descartes-08 is an innovative mRNA cell therapy candidate, a chimeric antigen receptor T-cell therapy (CAR-T) designed to target B-cell maturation antigen (BCMA). Unlike traditional DNA-based CAR-T therapies, Descartes-08 does not require preconditioning chemotherapy and is engineered to avoid the risk of genomic integration that can lead to cancerous transformations.

Previously, Descartes-08 was administered in a Phase 2 clinical trial for myasthenia gravis (MG), demonstrating sufficient safety to support outpatient administration with minimal observation. Dr. Carsten Brunn, President and CEO of Cartesian, highlighted the limitations of existing SLE treatments and expressed optimism that Descartes-08 could offer a safer and more effective outpatient alternative for patients who do not respond well to current therapies.

Dr. Susan Manzi of Allegheny Health Network and the Lupus Foundation of America emphasized the significance of this development for the lupus community. She hoped that Descartes-08 would show lasting clinical benefits for patients with B cell-mediated autoimmune diseases like lupus, particularly as an outpatient therapy.

The Phase 2 trial (NCT06038474) aims to enroll up to 30 adult patients with moderate to severe SLE that is refractory to immunosuppressant therapy. The primary focus of the trial is to evaluate the safety and tolerability of administering Descartes-08 without preconditioning chemotherapy. Secondary measures will assess the overall disease activity in participants.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by systemic inflammation affecting multiple organ systems, including the skin, joints, kidneys, brain, and heart. Symptoms can vary from mild to life-threatening and often include fatigue, joint pain, rash, and fever. In the United States alone, about 1.5 million people are affected by SLE.

Cartesian Therapeutics is a pioneering company in the field of mRNA cell therapies targeting autoimmune diseases. Descartes-08, its leading asset, is currently under Phase 2b clinical development for generalized myasthenia gravis and Phase 2 for SLE. The company has also planned a Phase 2 basket trial for additional autoimmune conditions. Another product in Cartesian's pipeline is Descartes-15, a next-generation autologous anti-BCMA mRNA CAR-T therapy.

With these developments, Cartesian Therapeutics aims to offer new, more effective treatment options for patients with autoimmune diseases, potentially transforming the treatment landscape for conditions like SLE and myasthenia gravis. The initiation of this clinical trial marks a significant step forward in the company's mission to deliver innovative therapies that address unmet medical needs.