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)

Part of paid clinical trials in Chicago, Illinois.

Sponsor: University of Chicago
Study ID: NCT06305286
Phase: PHASE1/PHASE2
Status: Recruiting

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Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy — DRUG
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.

Study Details

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.