A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
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.
Arms & interventions
- BiologicalDecartes-08
Autologous mRNA CAR T-cell therapy
- OtherPlacebo Drug
infusion without Decartes-08
Outcome measures
Primary
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.
Time frame: assessment at 4 months of study
Eligibility criteria
Study locations (23)
A40
Tucson, Arizona, 85718
A13
Carlsbad, California, 92011
A46
Los Angeles, California, 90095
A14
Orange, California, 92868
A21
Aurora, Colorado, 80045
A50
Washington D.C., District of Columbia, 20007
A48
Maitland, Florida, 32751
A10
Tampa, Florida, 33612
A53
O'Fallon, Illinois, 62269
A20
Fairway, Kansas, 66205
A16
Lexington, Kentucky, 40536
A38
Boston, Massachusetts, 02111
A12
Amherst, New York, 14226
A52
New York, New York, 10027
A47
New York, New York, 10065
A22
Chapel Hill, North Carolina, 27599
A39
Charlotte, North Carolina, 28204
A15
Portland, Oregon, 97239
A11
Philadelphia, Pennsylvania, 19104
A49
Pittsburgh, Pennsylvania, 15213
A43
Houston, Texas, 77030
A41
Seattle, Washington, 98195
A54
Milwaukee, Wisconsin, 53215