Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)

Summary

This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis

Timeline

Start

2019-12-04

Primary completion

2025-07-31

Completion

2026-03-31

Outcome

Met primary endpoint

paper significantly higher for those treated with Descartes-08 compared to placebo in the overall population (66.7% (n = 10/15) versus 27.3% (n = 3/11), P = 0.0472) PMID 41514038 ↗

release “Trial met primary endpoint with statistical significance, with 71% of myasthenia gravis patients treated with Descartes-08 observed” cartesiantherapeutics.com ↗

release “The trial achieved its primary endpoint with statistical significance” cartesiantherapeutics.com ↗

release “As previously announced , the trial met its primary endpoint and demonstrated a safety profile supporting outpatient administration of Descartes-08.” cartesiantherapeutics.com ↗

release “As previously announced, the trial met its primary endpoint and demonstrated a safety profile supporting outpatient administration of Descartes-08.” cartesiantherapeutics.com ↗

Publications

• Fedak RR, Ruggerie RN, Shan Y, Curvino EJ, de Sousa JF, Daniel S, Ngo-Casi M, Kamboh H, Vu T, Durmus H, Mozaffar T, Howard JF Jr, English EP, Benson A, Duvernay MT, Singer MS, Kalayoglu MV, Brunn C, Bodansky A, Anderson MS, DeRisi JL, Garcia ST, Yu DJL, Zorn KC, Kurtoglu M, Miljkovic MD, Stewart CA, Jewell CM; MG-001 Study Team. BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial. Nat Med. 2026 Mar;32(3):1118-1130. doi: 10.1038/s41591-025-04170-z. Epub 2026 Jan 9.
• Vu T, Durmus H, Rivner M, Shroff S, Ragole T, Myers B, Pasnoor M, Small G, Karam C, Vullaganti M, Peltier A, Sahagian G, Feinberg MH, Slanksy A, Barnett-Tapia C, Siddiqi Z, Gwathmey K, Badruddoja MA, Kamboh H, Ruggerie RN, Fedak RR, Stewart CA, Kurtoglu M, Kalayoglu M, Singer M, Jewell CM, Miljkovic MD, Dimachkie M, Mozaffar T, Howard JF Jr; MG-001 Study Team. BCMA-directed mRNA CAR T cell therapy for myasthenia gravis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2026 Mar;32(3):1131-1141. doi: 10.1038/s41591-025-04171-y. Epub 2026 Jan 9.
• Granit V, Benatar M, Kurtoglu M, Miljkovic MD, Chahin N, Sahagian G, Feinberg MH, Slansky A, Vu T, Jewell CM, Singer MS, Kalayoglu MV, Howard JF Jr, Mozaffar T; MG-001 Study Team. Safety and clinical activity of autologous RNA chimeric antigen receptor T-cell therapy in myasthenia gravis (MG-001): a prospective, multicentre, open-label, non-randomised phase 1b/2a study. Lancet Neurol. 2023 Jul;22(7):578-590. doi: 10.1016/S1474-4422(23)00194-1.
• Meisel A. Are CAR T cells the answer to myasthenia gravis therapy? Lancet Neurol. 2023 Jul;22(7):545-546. doi: 10.1016/S1474-4422(23)00211-9. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Descartes-08	Cell therapy	—	Intravenous

Indications