Breakthrough - T1DM and Chronic Kidney Disease

Tegoprubart is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. Tegoprubart is thought to work by dampening down our immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidneys, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. Tegoprubart is an experimental agent that is anticipated to prevent rejection without harming the islet cells. This study will test this hypothesis.

Human pancreatic islet cells is considered investigational because it is not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years. The islet transplant procedure involves inserting a thin, flexible tube called a catheter through a small cut in the upper abdomen. A radiologist uses x-rays and ultrasound to guide the catheter into the portal vein of the liver where the islet cells are delivered. This study of islet transplantation will test to see if islet transplantation is safe and effective; performing this study will help us find if this new medication Tegoprubart, combined with either MPA or everolimus and other medication the investigators have been using routinely so far, would protect sufficiently islet transplant from the destruction by the immune system, allowing participants to stop insulin and have improved blood glucose control.