Cartesian Aurora
What is the AURORA Study?
The aim of the AURORA Study is to assess the safety and effectiveness of an mRNA CAR T-cell therapy, known as Descartes-08, as a potential approach to treat generalized myasthenia gravis. Myasthenia gravis is an autoimmune disease, which means that the immune system mistakenly produces antibodies (proteins that normally protect us from bacteria and viruses) that attack the body’s own tissues and cells. These antibodies are called autoantibodies and in myasthenia gravis they attack the electrical signaling of muscles, causing muscle weakness. In generalized myasthenia gravis, muscle weakness affects muscles other than those of the eyes, such as those in the arms, legs, or those used for breathing. mRNA CAR T-cell therapy is a type of immunotherapy, which works by enhancing the body’s natural immune response. The process involves collecting T-cells, a type of white blood cell, from your body and modifying them to better recognize and attack problematic cells (in this case, the cells that are producing autoantibodies). The modified T-cells are then returned to your body.
Inclusion Criteria:
Approximately 100 people at multiple study centers globally are expected to take part.
You may be able to participate if you:
Are 18 years of age or older
Have acetylcholine receptor autoantibody-positive generalized myasthenia gravis
Experience muscle weakness that affects areas other than the eyes (with or without
additional weakness in the eye muscles).
There are other criteria that you will need to meet to qualify, which the study team will
discuss with you.
What does leukapheresis involve?
To collect T-cells used to manufacture the Descartes-08 study treatment, an apheresis machine will connect to your bloodstream through a catheter called a central or peripheral line. If your veins are not easily accessible, you may first have a temporary catheter inserted into a large vein in your chest. First, the machine will draw blood from you and collect the white blood cells from your blood. Second, the machine will return your red blood cells and platelets to you. This study visit is expected to last about 4–5 hours. Once the collection is complete, you will receive an appointment for your next visit. If you had a temporary central line placed for collection purposes, it will be removed
What does the infusion procedure involve?
The Descartes-08 cells or placebo prepared for you will be infused into your bloodstream through a catheter, which will be placed either in your chest or your arm. The infusion will take approximately 15 to 20 minutes. On some infusion days, a small sample of blood will be taken from your arm shortly after the infusion is given to measure the levels of Descartes-08 cells or placebo in your blood. You will have to remain at the study clinic for at least one hour after each infusion. The entire visit is expected to last about 4 hours. To reduce potential side effects of the Descartes-08 cell infusion, the study doctor will give you acetaminophen and an antihistamine before your infusion. You will also be asked to take over-the-counter acetaminophen every 6 hours for the first 24 hours after each infusion.
