This April 2021, Kelly Huang, Ph.D., Sommar Nettles, M.Sc., and Anisha Mannan, M.Sc. from American Gene Technologies' AGT103-T product team share clinical trial updates from Phase 1 of the drug product’s clinical trials for the HIV Cure Program. So far, 6 participants have been enrolled in the drug study at the Washington Health Institute and Georgetown University Medical Center. AGT currently has 5 products manufactured, with 1 product in progress, and we are working with the CMO to ensure products are manufactured under GMP conditions. The manufactured products are undergoing quality control lot release to ensure product quality and safety, and the team anticipates the first infusion of the drug product into clinical trial participants will happen in the spring. The trial design has also changed to increase the number of participants from 6 to 18, with new site initiation efforts occurring at the University of Maryland Medical School, Institute of Human Virology. Looking ahead, our team is designing a treatment interruption study for individuals who receive the AGT103-T product that tests product efficacy when antiretroviral treatment options for HIV are suspended for trial participants.
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