This phase II trial tests the safety and effectiveness of PD-L1 t-haNK with N-803 and cetuximab in treating patients with head and neck squamous cell carcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). PD-L1 t-haNK is a therapy that involves immune cells called natural killer (NK) cells, a part of the immune system which usually helps fight infections and prevent/fight cancer. These NK cells are generated from what is known as a cell line used for its tumor cell killing properties. PD-L1 t-haNK, are NK cells that have been genetically modified in a specialized laboratory to express proteins, including PD-L1, that help the NK cells grow and recognize your tumor cells. N-803 is a manufactured protein that stimulates your immune system. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. PD-L1 t-haNK, N-803, and cetuximab may work together to increase the activity and durability of the NK cells in fighting cancer cells in patients with recurrent and metastatic head and neck squamous cell carcinoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06239220.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Glenn J. Hanna
Dana-Farber Cancer InstituteStatus: Active
Contact: Glenn J. Hanna
PRIMARY OBJECTIVE:
I. To assess the anti-tumor activity of cetuximab combined with allogeneic PD-L1 tumor-targeted high-affinity natural killer cells (PD-L1 t-haNK) and nogapendekin alfa (N-803) (by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1).
SECONDARY OBJECTIVES:
I. To estimate safety and tolerability (Common Terminology Criteria for Adverse Events [CTCAE] v.5).
II. To summarize duration of response to therapy.
III. To estimate progression-free and overall survival.
EXPLORATORY OBJECTIVE:
I. To correlate circulating and tumor-based immune and molecular parameters with response and outcomes.
OUTLINE:
Patients receive PD-L1 t-haNK cells intravenously (IV) over 30 minutes, N-803 subcutaneously (SC), and cetuximab IV over 60-120 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may continue therapy after 1 year per sponsor-investigator. Patients also undergo blood sample collection, computed tomography (CT) scan, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT scan throughout study.
After completion of study treatment, patients are followed up every 3-4 months for up to 3 years and then every 6-12 months for up to 15 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorGlenn J. Hanna