Descartes-08

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).

About Descartes-08

Descartes-08 is a T-cell therapy that is custom-made from a patient’s own blood. The cells are engineered with an mRNA 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.

Find a study center near you

To see if Descartes-08 is right for you, please find your local study center from the list below, then contact a member of our study team to schedule your screening visit.

For additional study information, please visit: https://clinicaltrials.gov/ct2/show/NCT04146051

University of California Irvine

Principal investigator: Tahseen Mozaffar, MD

Clinical Research Coordinator: Yuna Muyshondt, MPH

Email: [email protected]

Clinical Research Coordinator: Sally Alcocer Medina

Email: [email protected]

Phone number: (714)-509-2117

Oregon Health & Science University

Principal Investigator: Nizar Chahin, MD
Clinical Research Coordinator: Diana Dimitrova, PhD

Email: [email protected]

Clinical Research Coordinator: Katie Lewis

Email: [email protected]
Phone number: (503)-494-0744

University of North Carolina

Principal Investigator: James Howard, MD
Clinical Research Coordinator: Manisha Chopra
Email:  [email protected]
Phone number: (919)-843-7857

The Research Center of Southern California

Principal Investigator: Gregory Sahagian, MD

Research Department Manager: April Tenorio, CCRC

Phone number: (760) 732-0557

Email: [email protected]

Neurology Associates, P.A.

Principal Investigator: Adam Slansky, MD
Research Department Manager: Kelly Holley
Phone number: (407) 646-5996
Email: [email protected]

SFM Clinical Research, LLC

Principal Investigator: Marc Feinberg, MD
Clinical Research Manager: Gabrielle DeMaria, MS
Email: [email protected]
Phone number: (561) 939-0333

Dent Neurologic Institute

Principal Investigator: Bennett Myers, MD
Clinical Research Coordinator: Anna Mattle, PharmD, MS 
Email: [email protected]

Phone number: (716) 961-9217

University of South Florida

Principal Investigator: Tuan Hoang Vu, MD
Clinical Research Coordinator: Naraly Requena
Email: [email protected]

Phone number: (813) 974-9413

Augusta University

Principal Investigator: Michael Rivner, MD
Clinical Research Coordinator: Brandy Quarles, MPH, CCRC 
Email: [email protected]

Phone number: (706) 721-0390

University of Alberta

Principal Investigator: Zaeem Siddiqi, MD
Clinical Research Coordinator: Faraz Hussain 
Email: [email protected]

Phone number: (780) 492-0004

Allegheny Health Network

Principal Investigator: George Small, MD
Clinical Research Coordinator: Dom Contestabile
Email: d[email protected]

Phone number: (412) 359-6293

University of Pennsylvania

Principal Investigator: Chafic Karam, MD
Clinical Research Coordinator: Sara-Claude Michon
Email: s[email protected]

Phone number: (215) 614-0027

University of Colorado

Principal Investigator: Thomas Ragole, MD
Clinical Research Coordinator: Brianna Blume
Email: b[email protected]

Clinical Research Coordinator: Emily Hyslop
Email: e[email protected]

Phone number: (303) 724-6386

University of Kansas

Principal Investigator: Mamatha Pasnoor, MD
Clinical Research Coordinator: Ali Ciersdorff
Email: [email protected]

Clinical Research Coordinator: Andrew Heim
Email: [email protected]

Phone number: (913) 945-9942

Virginia Commonwealth University

Principal Investigator: Kelly Gwathmey, MD
Clinical Research Coordinator: Melissa Hayes
Email: [email protected]

Phone number: (804) 360-4669

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.