Outpatient mRNA CAR-T skips lymphodepletion entirely — Phase 3 AURORA tests whether that tolerability comes at the cost of efficacy in MG

Cartesian Therapeutics is a clinical-stage company developing an mRNA cell therapy for myasthenia gravis that has not yet been approved, and is now testing in Phase 3 whether it can work effectively without the harsh pre-treatment typically required for this type of therapy.

Cartesian's Descartes-08 is an mRNA-based anti-BCMA CAR-T designed to deplete antibody-secreting cells in autoimmune diseases, with Phase 3 AURORA now enrolling roughly 100 patients with generalized myasthenia gravis. The thesis resolves on whether AURORA meets its primary endpoint, enabling a planned mid-2027 BLA filing. Direct CAR-T rivals rese-cel (Cabaletta) and miv-cel (Kyverna) are pursuing the same indication, compressing any first-mover window.