Final Operational Milestone #4

Persons with AIDS have one crucial missing part of their immunity, the immune cells, called T cells, that can recognize and kill the infection.  Thus, without this immunity, the HIV infection persists for years, and to control this infection the patient must take pills for a lifetime.  The goal of this project is to provide T cells that have been educated to recognize HIV infection and, to maintain high numbers of cells in the blood, to be activated by stimulation with a common virus called cytomegalovirus (CMV).  CMV is an infection in virtually all adults with HIV infection and can control CMV by means of CMV-reactive T cells.  We will educate T cells from people living with HIV by inserting a gene that can identify and target HIV-infected cells and placing this gene into their existing CMV-reactive T cells.  The engineered T cells are called CMV/HIV CAR T cells, and they will be able to recognize both CMV and HIV.  This CLIN1 grant has provided the support to test the safety of these CAR T cells in animals, to prepare the method of manufacturing that meets the Food and Drug Administration (FDA) requirements for testing in humans, and to write a clinical trial plan that is approved by an Institutional Review Board.  The investigators have completed the work necessary to begin this trial and have received FDA approval to move forward.