Doruk Erkan | Hospital for Special Surgery | New York, NY
Jason Knight | University of Michigan | Ann Arbor, MI
Hospital for Special Surgery, New York: Division of Rheumatology | New York, NY
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology | Ann Arbor, MI
New York University, Langone Health | New York, NY
Northwell Health | New York, NY
Johns Hopkins University | Baltimore, MD
Mayo Clinic | Rochester, MN
Weill Cornell | New York, NY
Duke University | Durham, NC
ITN093AI
Enrollment
In this research study, we will learn about the safety of the drug Darzalex® (daratumumab) in patients with antiphospholipid syndrome (APS), and will also learn whether it reduces levels of the antiphospholipid antibodies that cause APS.
Antiphospholipid syndrome (APS) is a rare and chronic autoimmune disorder that occurs when the body’s immune system mistakenly attacks healthy tissues and organs. Phospholipids are present on the surface of cells, including blood cells and cells that line blood vessels. In some people, the immune system makes antibodies to proteins that bind to phospholipids. These antiphospholipid antibodies attack the body and may increase the risk of blood clots in veins or arteries, and the risk of miscarriage or stillbirth.
Daratumumab is an antibody that targets a protein called CD38, which is on the surface of the immune cells that produce antiphospholipid antibodies (plasmablasts and plasma cells). In APS, daratumumab may work by eliminating these antiphospholipid antibody-producing cells, thereby reducing damage to the body caused by antiphospholipid antibodies.
Daratumumab is currently approved by the U.S. Food and Drug Administration (FDA) to treat a blood cancer called multiple myeloma. However, it has not been tested in patients with APS, and is considered an experimental treatment in the DARE-APS study.
Participation in DARE-APS will occur in two phases. During the treatment phase, participants will receive 8 weekly intravenous (IV) doses of daratumumab. The post-treatment follow-up phase will last an additional 10 months, during which 6 monitoring clinic visits will occur.
You may be eligible to participate in DARE-APS if you:
