drugset / Trial / NCT07592000

Breakthrough - T1DM and Chronic Kidney Disease

NCT07592000

Phase 1/2 Recruiting 10 enrolled University of Chicago Breakthrough T1D · collab
NaSingle-groupOpen-labelTreatment

Summary

Single arm- subject treated with Tegoprubart and everolimus. The purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components: * An investigational drug called Tegoprubart and * Human pancreatic islet cells Both Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years. Assess safety, tolerability, and efficacy of transplanted islet cells and immunomodulation with Tegoprubart in combination with anti-thymocyte globulin (ATG), etanercept and with everolimus in adults with brittle T1D and chronic kidney disease (stage 2-3a).

Timeline

Start
2027-04-29
Primary completion
2030-01-31
Completion
2030-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Human pancreatic islet cells Cell therapy Other
Subject Tegoprubart Monoclonal antibody