Pilot Study of Safety and Effectiveness of Tegoprubart With Islet Cell Transplantation for Type 1 Diabetes and Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating a treatment approach for adults with brittle Type 1 Diabetes Mellitus T1D and chronic kidney disease stage 2-3a. The study aims to assess the safety, tolerability, and effectiveness of an investigational regimen combining two experimental components Tegoprubart, a monoclonal antibody designed to reduce immune attack on transplanted cells, and human pancreatic islet cells. These islet cells are transplanted to potentially restore insulin production in patients who have difficulty controlling blood sugar and experience severe hypoglycemic events. This is a Phase 12 pilot study supported by the University of Chicago and funded by Breakthrough T1D. Participants receive pancreatic islet cells obtained from deceased donors, transplanted via a catheter guided into the livers portal vein under imaging. The study treatment involves Tegoprubart combined with immunosuppressive drugs such as anti-thymocyte globulin ATG, etanercept, and everolimus, aiming to protect the transplanted cells without harming them, unlike traditional calcineurin inhibitors. The investigational drug Tegoprubart is being tested for safety and effectiveness in preventing immune rejection, alongside standard medications. The study lasts about five years, including ongoing monitoring. During the study, participants will be regularly evaluated for insulin production, blood sugar control, kidney function, and safety outcomes. Assessments include continuous glucose monitoring, mixed-meal tolerance tests, and kidney function tests such as estimated glomerular filtration rate eGFR. Researchers will track outcomes like insulin independence, frequency of severe hypoglycemic events, and progression of kidney disease annually for up to five years. Safety monitoring includes observing for infections and adverse events. Participants will follow study procedures and visits as scheduled throughout the study duration.

Breakthrough - T1DM and Chronic Kidney Disease