Donor-Alloantigen-Reactive Regulatory T Cell Therapy in Liver Transplantation (deLTa)

The purpose of this study is to look at the safety of: 1. Taking a specific combination of immunosuppressant drugs after liver transplantation 2. Receiving one of three different doses of donor reactive Tregs while taking this specific combination of drugs One goal of this study is to see if a specific combination of immunosuppressants that has been designed to increase Treg numbers is safe. None of the immunosuppressants in this study are experimental but the combination of medications is new. Patients in this study will receive the new combination of medications. Later in the study, white blood cells will be removed from study participants’ blood. This can be done by drawing blood and then taking out the white blood cells in the lab, or by using a procedure called “leukapheresis.” These cells will be processed to make the donor reactive Treg infusion that will be given back to the transplant recipient. Three increasing doses of Tregs will be tested for safety in this study. The study team will collect information about the immunosuppressants and any problems that may arise. Blood and liver biopsy samples will be collected to learn more about how cells behave when using the study immunosuppressants after liver transplantation. For subjects receiving Tregs, the dose of donor reactive Tregs will be recorded and participants will be monitored for side effects. Additional laboratory testing will be done to see if the Tregs that were given can be found in the blood and liver samples. Some of the tests performed on samples will include looking at your genes (genetic testing). Genetic tests look at an individual’s inherited characteristics, found in DNA, which is present in every cell in the body. DNA contains information needed to construct and operate the human body. For example, researchers may want to see whether a gene might be switched “on” or “off” at the time of rejection or whether the Tregs that are given switch genes on or off. The study team hopes to understand what gene patterns might be linked to good liver transplant outcomes.