Study on PD-L1 t-haNK, N-803, and Cetuximab for Advanced Head and Neck Cancer

Sponsor: Glenn J. Hanna

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06239220

Provider View

This clinical trial is testing a new combination of treatments to see if they are safe and effective for people with advanced head and neck cancer. The treatments include modified immune cells, a protein that boosts the immune system, and a targeted antibody.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new combination of treatments for advanced head and neck cancer. The treatments include PD-L1 t-haNK (modified immune cells), N-803 (a protein that stimulates the immune system), and cetuximab (a targeted antibody). These treatments may work together to help the immune system fight cancer cells more effectively. While cetuximab is already approved for treating advanced head and neck cancer, PD-L1 t-haNK and N-803 are not yet approved for this use. Participants will receive these treatments every two weeks for at least a year and will be monitored for up to 15 years. About 25 people are expected to participate in this study.

Description

This study is exploring a new combination of treatments for advanced head and neck cancer. The treatments include PD-L1 t-haNK, which are modified immune cells, N-803, a protein that helps boost the immune system, and cetuximab, a targeted antibody. The goal is to see if these treatments can work together to help the immune system fight cancer more effectively.

The U.S. Food and Drug Administration (FDA) has approved cetuximab for treating advanced head and neck cancer, but PD-L1 t-haNK and N-803 are still being studied. Participants will undergo various procedures, including CT scans, MRI, PET scans, blood tests, and heart tests, to monitor their health and the treatment's effects.

Participants will receive the study treatment every two weeks for at least one year and will be followed for up to 15 years, as required by the FDA for those receiving genetically modified cells. The study aims to include about 25 participants, and the treatments are provided by ImmunityBio.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) that is recurrent, metastatic, or advanced and cannot be cured or removed by surgery.
  • Have at least one measurable tumor that can be accurately measured by scans.
  • Have received 1 or 2 previous treatments for advanced head and neck cancer, including one with anti-PD-1/L1 therapy.
  • Be at least 18 years old.
  • Provide information on tumor PD-L1 expression and HPV status if available.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Have tumor measurements documented from imaging within 28 days before starting the study.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 6 months after the last dose. Men must use a condom during the study and for 6 months after.
  • Be willing to provide written informed consent for the trial.

Exclusion Criteria

  • Have been treated with 3 or more lines of systemic therapy for advanced head and neck cancer.
  • Have received radiation therapy within 10 days before starting the study.
  • Have had a solid organ transplant.
  • Have active cancer spread to the brain or spinal cord, unless previously treated and stable.
  • Have a significant autoimmune disease requiring active treatment.
  • Have uncontrolled illness, such as active infection or recent heart problems.
  • Have another progressing cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
  • Have active hepatitis B or C infection, unless controlled. HIV-positive patients are eligible if their viral load is undetectable.
  • Be pregnant, breastfeeding, or planning to conceive or father children during the study and for 120 days after the last treatment. Women must use two methods of contraception if they could become pregnant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.