A Pilot Study to Evaluate the Feasibility and Safety of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV-HIV CAR) T Cells in People Living With HIV

What this Trial Is About

Human immunodeficiency virus type 1 (HIV-1) causes a lifelong infection that can lead to acquired immunodeficiency syndrome (AIDS). Although combination anti-retroviral therapy (ART) suppresses the virus to undetectable levels, it cannot eliminate latent reservoirs of HIV-1. This research aims to evaluate adoptive cellular immunotherapy using chimeric antigen receptor (CAR) T cells targeting HIV-1 envelope protein gp120. The study focuses on using CMV-specific T cells as a basis for HIV-CAR T cells, leveraging the body's existing immune response to cytomegalovirus (CMV) to help maintain the CAR T cells' presence in people living with HIV (PLWH). Participants will temporarily stop their ART for 4 days before leukapheresis to avoid interference with the manufacturing of HIV-CAR T cells. After leukapheresis, ART is resumed immediately. If needed, a second leukapheresis may occur at least 3 weeks later with the same ART interruption. Once the CAR T cell product is ready, participants receive a single intravenous infusion of autologous CMV/HIV-CAR T cells on Day 0. The study may explore up to three different doses ranging from 5 million to 50 million EGFR+ T cells. Participants will be closely monitored for up to 28 days after infusion for dose-limiting toxicities and overall safety. Researchers will assess CD4+ T cell counts, HIV RNA levels, cytokine levels, and the presence of CMV/HIV-CAR T cells in the blood. The study aims to determine the feasibility and safety of this approach and establish the recommended dose for future research. Total participation includes ART interruptions, leukapheresis procedures, infusion, and post-infusion monitoring.

CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS