Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years at the time of signing the consent form
• People who have been diagnosed (through lab testing of tissue or cells) with squamous cell carcinoma of the mouth, throat, voice box, or the area connecting the throat to the oesophagus, where the cancer has come back or spread and cannot be treated with surgery or radiation aimed at curing the disease
• People whose tumour has been tested by a central lab and meets specific levels of two proteins (EGFR and HER2) found on the surface of cancer cells, as defined by the trial's testing requirements (confirm with trial site)
• People whose cancer has continued to grow or spread after receiving at least one previous treatment for recurrent or metastatic disease, which must have included platinum-based chemotherapy and an immunotherapy drug targeting PD-1 or PD-L1, unless those treatments were not suitable — prior treatment with cetuximab is also allowed
• People who have at least one area of cancer that can be measured using standard imaging criteria (RECIST 1.1)
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale used by medical teams (ECOG scale), meaning they are either fully active or able to carry out light activity
• People whose blood test results show that the bone marrow, kidneys, liver, heart, and lungs are functioning within the levels the trial requires
• People with a life expectancy of at least 12 weeks
• People who have stored tumour tissue available, or who are willing to provide a fresh tumour sample for testing, and who agree to provide blood samples during the trial and, if medically safe, an optional additional tissue sample
• People who are not pregnant, with a negative pregnancy test result if there is any possibility of pregnancy, and who agree to use highly effective contraception during treatment and for the follow-up period defined by the trial
• People who are able to understand the trial and sign the informed consent form

Who may not be able to join:

• People whose cancer is nasopharyngeal carcinoma, salivary gland cancer, skin squamous cell carcinoma, a non-squamous cancer type, or a cancer where the original starting point in the body is unknown
• People who have cancer that has spread to the brain or the lining of the brain or spinal cord, where that spread has not been treated, is unstable, or is causing symptoms
• People who have previously received a type of cell therapy that uses genetically modified immune cells (such as CAR-T, CAR-NK, or TCR-T therapy) within the trial's required washout period, or who have had a bone marrow transplant from another person and are currently experiencing graft-versus-host disease
• People with an active infection that is not under control, including bacterial, fungal, or viral infections; hepatitis B or C with a detectable level of virus in the blood; or HIV that is not controlled
• People with an active autoimmune disease that requires ongoing treatment to suppress the immune system, or who are using corticosteroid medication above the level the trial allows before the pre-treatment phase
• People with significant lung disease, dependence on oxygen, or another serious lung condition that would increase the risks associated with cell therapy
• People with significant heart or cardiovascular problems, including a recent heart attack, unstable chest pain, an uncontrolled irregular heartbeat, uncontrolled high blood pressure, or heart failure causing symptoms
• People who have had major surgery within 28 days before the pre-treatment phase of the trial, or who have received other cancer treatments or experimental therapies within the trial's required washout period
• People who are pregnant or breastfeeding
• People with a known severe allergic reaction to fludarabine, cyclophosphamide, or any components of the cell therapy product used in this trial
• People with any medical, mental health, or social circumstances that, in the treating doctor's judgement, would affect safety, the ability to follow the trial's requirements, or the ability to give informed consent

Important: Always verify eligibility with the trial site directly before applying.