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.
Patient must be at least 18 years of age.
Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of Sscreening.
MG-Activities of Daily Living (MG ADL) total score ≥ 6.
Concomitant immunosuppressive drugs must be deemed necessary by the investigator. The dose must be stable for a minimum of 8 weeks prior to Baseline visit.
Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
Diagnosis of gMG within 12 months of screening.
No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
Diagnosis of a neuromuscular disease other than gMG.
Crossover
Decartes-08
Biological/VaccineAutologous mRNA CAR T-cell therapy
Placebo Drug
Other interventioninfusion without Decartes-08
Myasthenia Gravis Activities of Daily Living (MG-ADL)
To evaluate the efficacy of Descartes-08 as assessed by the proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders at Month 4.
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