clinical study of an investigational cell therapy for treatment of generalized Myasthenia Gravis (MG)
What is Myasthenia Gravis?
Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by weakness and fatigue of muscles. The clinical course of MG is variable but usually progressive. Symptoms typically emerge in the eyes (e.g., drooping eyes, double vision, blurred vision) (ocular MG) or progress to involve the face, throat and limbs (generalized MG).
Descartes-08 is a T-cell therapy that is custom-made from a patient’s own blood. The cells are engineered with an mRNA designed to redirect them to find and kill antibody-producing plasma cells. It is hoped that these T-cells, when administered back to the patient, will find and kill the aberrant plasma cells that produce the pathogenic antibodies in MG.
Who can participate in the study?
You may be eligible to participate in this clinical study if you are over the age of 18 and:
- You have Generalized Myasthenia Gravis
- Concomitant immunosuppressive drugs are deemed necessary
Only a member of our study team can determine your final eligibility. To learn more, please find your local study center from the list below and schedule a screening visit.
What can participants expect?
Descartes-08 is an investigational drug designed to study the safety and possible benefits in patients with MG.
Participants will undergo leukapheresis, where T cells will be collected from your blood and sent to a lab to be turned into Descartes-08 cells. You will then be randomized to receive either placebo or Descartes-08 for 6 weeks. If you receive placebo, you will have the chance to cross over and receive Descartes-08. Participation will last approximately 12-15 months and require several visits to the study center.
Frequently asked questions
During a clinical study, a medication is being evaluated to determine whether or not it may help you. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams, and other types of assessments that are necessary to gather the required information about the study medication. All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.
There will be approximately 30 patients taking part in this study at multiple study centers across the U.S.
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, and for any reason.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to market, benefiting thousands of people who also have the disease or condition.
This study is regulated by the U.S. Food and Drug Administration (FDA) and independent local and central Institutional Review Boards (IRB) to ensure that the study conforms to regulatory standards set forth for U.S. clinical trials. You will have an opportunity to review participation risks in detail prior to deciding to enroll in the study.
The study centers and Cartesian Therapeutics, Inc. are responsible for conducting this clinical trial.