A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Acetylcholine Receptor Antibody-Positive Generalized Myasthenia Gravis
Latest Information Update: 08 Feb 2025
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At a glance
- Drugs Descartes 08 (Primary)
- Indications Myasthenia gravis
- Focus Registrational; Therapeutic Use
- Acronyms AURORA
- Sponsors Cartesian Therapeutics
- 30 Jan 2025 Status changed from planning to recruiting.
- 27 Jan 2025 According to a Cartesian Therapeutics media release,company announced it has received written agreement from the US Food and Drug Administration under the Special Protocol Assessment process on the overall design of the Company's planned Phase 3 AURORA trial for Descartes-08 in myasthenia gravis. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future BLA for Descartes-08 in MG, subject to the ultimate outcome of the trial.
- 10 Dec 2024 New trial record