Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 Trial of Descartes-08 in Patients With Myasthenia Gravis

Cartesian Therapeutics, Inc. recently announced the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

“With the first participant now successfully enrolled, commencement of our Phase 3 AURORA trial represents a significant milestone in our mission to deliver a differentiated, durable treatment option to patients with MG,” said Carsten Brunn, PhD, President and Chief Executive Officer of Cartesian. “With sustained benefits observed through 12 months in our Phase 2b trial, we believe Descartes-08 has the potential to transform the current MG treatment paradigm with just a single course of therapy.”

“Marked by chronic use of steroids and other immunosuppressants while often delivering only limited efficacy, the current standard of care for patients with MG is inadequate,” said James (Chip) F. Howard, Jr., MD, Cartesian Clinical Advisor and Professor of Neurology, Medicine, and Allied Health at the University of North Carolina School of Medicine. “Supported by compelling results from the Phase 2b trial, I firmly believe that Descartes-08 has the potential to serve as a safe, flexible, and durable treatment option for patients with MG. I look forward to helping advance this important study.”

The Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo.

In April 2025, the company announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in the MG-ADL score at Month 12. The deepest and most compelling sustained responses were  observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration. 

Cartesian Therapeutics is a clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, visit www.cartesiantherapeutics.com or follow on LinkedIn or X, formerly known as Twitter.