Cartesian Therapeutics is a clinical-stage biotechnology company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The company's lead candidate, Descartes-08, is an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor (CAR)-T cell therapy. Unlike conventional DNA-based CAR-T therapies, Descartes-08 does not require preconditioning chemotherapy or integrating vectors and can be administered in an outpatient setting without the risk of genomic integration. This mRNA-engineered CAR-T therapy is currently in Phase IIb clinical development for patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder causing muscle weakness and fatigue.
Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the US FDA for the treatment of MG. Cartesian expected to hold an End-of-Phase II meeting with the FDA by year-end 2024. The company had also initiated a Phase II study evaluating Descartes-08 in patients with systemic lupus erythematosus (SLE) and had plans for Phase II basket trials in additional autoimmune indications.
In January 2024, the FDA cleared Cartesian's IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T candidate. Planning was underway for a Phase I dose-escalation study in multiple myeloma, with subsequent evaluation in autoimmune indications.
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