Outcomes for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) remain quite poor with survival measured in months in most cases. Immunotherapy, specifically immune checkpoint inhibitors (ICIs), have improved survival; however, response rates remain under 20%. SCCHN patients who failed ICIs represent a growing population, thus there is an urgent need for more treatment options. Natural killer (NK) cells are immune cells that kill any cells that do not have the “self” protein such as infected cells, bacteria, and tumor cells. The researchers found they could induce a memory-like response in NK cells towards certain targets by using certain signaling proteins. One of these signaling proteins is IL-15. For this study, it has been enhanced to be more potent and is called N-803. This phase I trial will establish the safety for cytokine-induced memory-like (CIML) NK cells in combination with N-803 in patients with recurrent or metastatic SCCHN. There will also be a subset of patients treated with an ICI in addition to CIML NKs and N-803.
Trial Registration: ClinicalTrials.gov Identifier: NCT04290546