NCT06799247

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cartesian Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.

Conditions

• Myasthaenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	Decartes-08	Autologous mRNA CAR T-cell therapy
OTHER	Placebo Drug	infusion without Decartes-08

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-11-30
• Completion: 2027-09-30
• First posted: 2025-01-29
• Last updated: 2026-03-24

Locations

34 sites across 8 countries: United States, Canada, Italy, Poland, Serbia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study