Safety and durability of AGT103-T autologous T cell therapy for HIV infection in a Phase 1 trial.

ABSTRACT: The cell and gene therapy product AGT103-T was designed to restore the Gag-specific CD4+ T cell response in persons with chronic HIV disease who are receiving antiretroviral therapy. This autologous, genetically engineered cell product is under investigation in a Phase 1 clinical trial (NCT03215004). Trial participants were conditioned with cyclophosphamide approximately 1 week before receiving a one-time low (< 10⁹ genetically modified CD4+ T cells) or high (≥10⁹ genetically modified CD4+ T cells) dose of AGT103-T, delivering between 2 and 21 million genetically modified cells per kilogram (kg) body weight. There were no serious adverse events (SAEs) and all adverse events (AEs) were mild. Genetically modified AGT103-T cells were detected in most of the participant b

SUBMITTER: Muvarak N 

PROVIDER: S-EPMC9701732 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature