HIV: First patient treated with potentially curative HIV cure via cell and gene therapy (AGT103-T) made by American Gene Technologies
The first-in-human study will evaluate the safety and efficacy of AGT103-T, a single dose, autologous cell therapy intended to cure HIV, in up to six participants.
AGT’s Gag-specific AGT103-T is a genetically modified cell product made from an individual’s own cells administered to patients with an ex vivo lentiviral vector-based gene therapy. The therapy is developed over an 11 –day process to increase the number of HIV specific T-cells resistant to HIV in order to better fight the virus.
In preclinical studies, AGT103-T demonstrated the ability to clear HIV and HIV-infected cells. The research was replicated in collaboration with the National Institute of Allergy and Infectious Disease (NIAID). AGT believes this gene therapy can restore the immune system’s ability to remove infected cells from the patient and decrease or eliminate the need for lifelong antiretroviral treatment.
In the Phase I RePAIR trial (Restore Potent Antiviral Immune Responses), patients are infused with their own cells in order to repair the immune system damage caused by HIV infection. The AGT-developed gene therapy is designed to repair depleted CD4 cells, or helper T cells.
The first infusion took place at Washington Health Institute in Washington, D.C. on May 19, 2021. The primary endpoint of the Phase I study is safety. Secondary endpoints include an evaluation of responses to treatment including changes in the immune response to HIV. Those patients who participate in the study will be followed for six months. At the end of that time, they will then be enrolled in a 15-year-long follow up study mandated by the FDA for all gene therapy trials.