Article
作者: Datar, Anushree ; Sohai, Danielle K ; Motta, Cecilia ; Mota, Talia M ; Zhang, Anqing ; Tanna, Jay ; Reynolds, Emily ; Hanley, Patrick J ; MacLaren Ehui, Lynsay ; Shibli, Abeer ; Kukadiya, Divyesh ; Dwyer, Bridget ; Keller, Michael D ; Cruz, Conrad Russell Y ; Wilson, Andrew ; Lynch, Rebecca ; Huynh, Tan T ; Lazarski, Christopher ; Copertino, Dennis C ; Hoq, Fahmida ; Henn, Sarah ; Brad Jones, R ; Bollard, Catherine M ; McCann, Chase D ; Kinloch, Natalie N ; Chansky, Pamela A ; Brumme, Zabrina L ; Lang, Haili ; Conce Alberto, Winiffer D
Novel cellular therapies may enable HIV control or cure. HIV-specific T cells targeting conserved immunogenic protein regions of HIV Gag/Pol and the entirety of HIV Nef, termed HST-NEETs, eliminate HIV infected cells in vitro. Here we enroll seven participants in an open-label, single-arm phase 1 study (NCT03485963) to evaluate the safety (primary endpoint) of two autologous administrations of HST-NEET products without prescribed lymphodepletion. Adults with well-controlled HIV on anti-retroviral therapy are eligible. Six participants completed safety monitoring. No serious product-related toxicities are observed. Secondary endpoints are to assess expansion and persistence of HIV-reactive T cell clones, and changes to the HIV reservoir for each infused participant. HIV-specific T cell and HIV anti-Env antibody responses increase in two participants after infusion two. A trend towards decreasing levels of intact proviruses is observed in 2 participants. Three participants show persistence of HIV-reactive, product-associated T cell clones for ≥40 weeks post infusions. HST-NEETs infusions are well-tolerated. Future trials are needed to evaluate the efficacy of HST-NEETs in this population.