Autologous HIV-specific T cell therapy targeting conserved epitopes is well-tolerated in six adults with HIV: an open-label, single-arm phase 1 study

Danielle K. Sohai, Michael D. Keller, Patrick J. Hanley, Fahmida Hoq, Divyesh Kukadiya, Anushree Datar, Emily Reynolds, Dennis C. Copertino, Christopher Lazarski, Chase D. McCann, Jay Tanna, Abeer Shibli, Haili Lang, Anqing Zhang, Pamela A. Chansky, Cecilia Motta, Tan T. Huynh, Bridget Dwyer, Andrew Wilson, Rebecca Lynch, Talia M. Mota, Winiffer D. Conce Alberto, Zabrina L. Brumme, Natalie N. Kinloch, Conrad Russell Y. Cruz, Lynsay MacLaren Ehui, Sarah Henn, R. Brad Jones and Catherine M. Bollard ()
Additional contact information
Danielle K. Sohai: Children’s National Hospital
Michael D. Keller: Children’s National Hospital
Patrick J. Hanley: Children’s National Hospital
Fahmida Hoq: Children’s National Hospital
Divyesh Kukadiya: Children’s National Hospital
Anushree Datar: Children’s National Hospital
Emily Reynolds: Children’s National Hospital
Dennis C. Copertino: Weill-Cornell Medicine
Christopher Lazarski: Children’s National Hospital
Chase D. McCann: Children’s National Hospital
Jay Tanna: Children’s National Hospital
Abeer Shibli: Children’s National Hospital
Haili Lang: Children’s National Hospital
Anqing Zhang: Children’s National Hospital
Pamela A. Chansky: Children’s National Hospital
Cecilia Motta: Children’s National Hospital
Tan T. Huynh: Weill-Cornell Medicine
Bridget Dwyer: The George Washington University
Andrew Wilson: The George Washington University
Rebecca Lynch: The George Washington University
Talia M. Mota: Weill-Cornell Medicine
Winiffer D. Conce Alberto: Weill-Cornell Medicine
Zabrina L. Brumme: Simon Fraser University
Natalie N. Kinloch: Simon Fraser University
Conrad Russell Y. Cruz: Children’s National Hospital
Lynsay MacLaren Ehui: Whitman-Walker Health
Sarah Henn: Whitman-Walker Health
R. Brad Jones: Weill-Cornell Medicine
Catherine M. Bollard: Children’s National Hospital

Nature Communications, 2025, vol. 16, issue 1, 1-15

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-59810-2

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