Jeffrey S Miller, Joshua Rhein, Zachary B Davis, Sarah Cooley, David McKenna, Jodi Anderson, Kevin Escandón, Garritt Wieking, Jarrett Reichel, Ann Thorkelson, Siri Jorstad, Jeffrey T Safrit, Patrick Soon-Shiong, Gregory J Beilman, Jeffrey G Chipman, Timothy W Schacker

Safety and virologic impact of haploidentical NK cells plus IL-2 or N-803 in HIV infection

  • Infectious Diseases
  • Immunology and Allergy

Abstract Background NK cells are dysfunctional in chronic HIV infection as they are not able to clear virus. We hypothesized that an infusion of NK cells, supported by IL-2 or IL-15, could decrease virus-producing cells in the lymphatic tissues. Methods We conducted a phase 1 pilot study in 6 persons living with HIV (PLHIV), where a single infusion of haploidentical related donor NK cells was given plus either IL-2 or N-803 (an IL-15 superagonist). Results The approach was well tolerated with no unexpected adverse events. We did not pre-treat recipients with cyclophosphamide or fludarabine to “make immunologic space”, reasoning that PLHIV on stable antiretroviral treatment remain T-cell depleted in lymphatic tissues. We found donor cells remained detectable in blood for up to 8 days (like what is seen in cancer pretreatment with lymphodepleting chemotherapy) and in the lymph nodes and rectum up to 28 days. There was a moderate decrease in the frequency of viral RNA+ cells in lymph nodes. Conclusion There was a moderate decrease in HIV-producing cells in lymph nodes. Further studies are warranted to determine the impact of healthy NK cells on HIV reservoirs and if restoring NK-cell function could be part of an HIV cure strategy.

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