Warning, it’s a press release:
Gaithersburg, MD, January 31, 2023 – Cartesian Therapeutics, a fully integrated, clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases and cancer, has dosed the first participant in its Phase 2b randomized controlled trial (RCT) for generalized myasthenia gravis (MG), an autoimmune disorder that causes muscle weakness and fatigue. The RCT will evaluate the efficacy and safety of the company’s lead asset, Descartes-08, a first-in-class, RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T).
To the company’s knowledge, this is the first placebo-controlled study of an engineered cell therapy, and the most advanced investigational cell therapy in clinical development for any autoimmune disease. Descartes-08 is administered over 6 weekly outpatient visits and requires no preconditioning chemotherapy.
The manuscript from the open-label study is almost done, but some of the data was presented back in September 2022 (and available on YouTube). I also talked about the study in an MGFA webinar.
RCTs FTW.