RecruitingPhase 1Phase 2NCT06305286

Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)

A Pilot Study Assessing the Safety of Using a Monoclonal Antibody Against Cluster of Differentiation 40 (CD40) Ligand to Achieve a Calcineurin Inhibitor-free Immunosuppression Regimen in Patients With Type 1 Diabetes Mellitus (T1D) and Problematic Hypoglycemia Undergoing Islet Cell Transplantation

Sponsor

University of Chicago

Enrollment

70 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

Summary

Tegoprubart (AT-1501) is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's 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 (AT-1501) is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. Tegoprubart (AT-1501) is an experimental agent that is anticipated to prevent rejection without harming the islet cells.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of transplanted insulin-producing cells (islet cells) and a new immune-suppressing antibody drug can safely improve blood sugar control in adults with very unstable, hard-to-manage type 1 diabetes. **You may be eligible if...** - You are between 18 and 65 years old - You have had type 1 diabetes for at least 5 years, diagnosed before age 40 - You use continuous glucose monitoring and either an insulin pump or multiple daily injections - Despite careful management, you have had at least 3 unexplained severe low blood sugar episodes in the past year that were not caused by missed meals or dosing errors - You are under the care of an endocrinologist with at least 4 visits in the past 12 months **You may NOT be eligible if...** - Your diabetes is well controlled - You have health conditions that make islet transplantation or immune suppression unsafe - You do not meet the study's strict criteria for unstable (brittle) type 1 diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIslet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy

Tegoprubart (AT-1501) is a monoclonal antibody for Injection is a humanized immunoglobulin G1 (IgG1) kappa monoclonal anti-CD40L antibody that blocks CD40L binding to its receptor, CD40. Safety and effectiveness of islet transplantation with Tegoprubart- based, calcineurin inhibitor-free (tacrolimus-free) immunosupression regimen is being tested. The goal is improve outcomes of islet transplantation avoiding toxicity and side effect of standard, tacrolimus- based immunosupression therapy.