NEW YORK – Cartesian Therapeutics said Tuesday that it has dosed the first patient in a Phase I clinical trial of its mRNA CAR T-cell therapy Descartes-15 in relapsed or refractory multiple myeloma.
The first-in-human trial aims to enroll 41 patients to examine the safety and tolerability of Descartes-15. The autologous anti-B cell maturation antigen (BCMA) mRNA-engineered CAR T-cell therapy involves extracting T cells from patients' blood samples and engineering them to target BCMA cell-surface proteins once reinfused back into the body. The Gaithersburg, Maryland-based company has developed Descartes-15 to be administered without the need for preconditioning chemotherapy.
According to Cartesian, Descartes-15 in preclinical studies lead to a tenfold increase in CAR expression and selective target-specific killing, as compared to its lead candidate Descartes-08, which is being tested in a Phase IIb study in myasthenia gravis and is under development in systemic lupus erythematosus and other autoimmune diseases.
Secondary endpoints of the Descartes-15 study include evaluating initial response and progression-free survival.
"We believe that Descartes-15, which was designed leveraging our novel mRNA platform, could serve as a highly potent next-generation cell therapy with the ability to be dosed in the outpatient setting without preconditioning chemotherapy," Cartesian President and CEO Carsten Brunn said in a statement.
Cartesian also plans to study Descartes-15 in other autoimmune indications following the Phase I trial.