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Breakthrough - T1DM and Chronic Kidney Disease

NCT07592000 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Tegoprubart

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.

BIOLOGICAL

Islet Cell Transplant

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.

Sponsors & Collaborators

  • Breakthrough T1D

    collaborator OTHER

  • University of Chicago

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2030-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592000 on ClinicalTrials.gov