Phase 2 Study of PD-L1 t-haNK, NAI IL-15 Superagonist, and Cetuximab for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining PD-L1 t-haNK modified immune cells, NAI a manufactured protein that stimulates the immune system, and cetuximab a targeted antibody to treat advanced head and neck cancer. This Phase 2 trial focuses on patients with recurrent, metastatic, or incurable head and neck squamous cell carcinoma. The FDA has approved cetuximab for this type of cancer, but PD-L1 t-haNK and NAI are investigational in this setting. Participants receive doses of PD-L1 t-haNK via intravenous infusion, NAI through subcutaneous injection, and cetuximab via intravenous infusion every 2 weeks in a 28-day cycle. The study includes two dose levels with possible adjustments due to side effects. Imaging scans like CT, MRI, and PET are performed every 8 weeks during treatment. Treatment continues for at least one year, followed by a follow-up period every 3-4 months for up to 3 years and then every 6-12 months for up to 15 years to monitor long-term effects. During the study, participants undergo regular clinical visits for treatment doses, imaging scans to assess tumor response, blood tests, and electrocardiograms. Researchers measure response rates to treatment through imaging every two cycles about every 8 weeks over the first year. Safety is monitored throughout treatment and up to 30 days afterward. Participants will be followed for up to 15 years to track long-term outcomes and any late effects related to the genetically modified cells administered.

PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC