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
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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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