Cartesian Therapeutics, Inc. 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. 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.