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 who have been diagnosed with metastatic or recurring/treatment-resistant cancer that has tested positive for the HPV-16 virus strain, confirmed through laboratory testing.
• People whose tumor tissue and/or blood has been confirmed to carry the HPV-16 type through a certified laboratory test.
• People who carry a specific immune system marker called HLA-A*02:01, confirmed through certified laboratory testing before a blood collection procedure called apheresis.
• People whose cancer can be measured on scans using a standard set of medical measurement guidelines (called RECIST v1.1).
• People aged 18 or older.
• People who are generally well enough to carry out normal daily activities, with only mild symptoms at most (confirmed with trial site regarding specific fitness scoring).
• People who have already received standard first-line cancer treatment, or who have been fully informed about standard treatment options and have formally decided not to pursue them.
• People with three or fewer brain tumours that have already been treated with surgery or targeted radiation, where the treated areas have been stable for at least one month and recovery from surgery is complete.
• Women under 55, or any woman who has had a menstrual period in the last 12 months, who have a negative pregnancy test (not required for women who have had both ovaries or their uterus removed).
• People who agree to use reliable contraception before joining the trial and for four months after treatment, and who agree to notify their treating doctor immediately if pregnancy occurs or is suspected during the trial.
• People who test negative for HIV, active hepatitis B, and hepatitis C infection.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning adequately (specific thresholds will be checked by the trial site).
• People whose blood clotting function falls within an acceptable range, or who are on blood-thinning medication with stable, well-managed levels and no history of serious bleeding.
• People for whom at least four weeks have passed since their last systemic cancer treatment, and whose side effects from prior treatment have largely resolved.
• People who are able to understand and are willing to sign a written consent form.
• People who agree to participate in two related long-term follow-up and sample collection studies linked to this trial.
• People who have had minor surgical procedures within the past three weeks may still be considered, as long as any side effects have mostly resolved.

Who may not be able to join:

• People with uncontrolled serious illness at the time of treatment, such as an active infection, unstable heart conditions, or psychiatric or personal circumstances that would make it difficult to follow the trial requirements.
• People with a history of severe allergic reactions to substances similar to those used in this trial.
• People with a history of heart bypass surgery or symptoms of reduced blood flow to the heart, unless a normal cardiac stress test result has been obtained.
• People whose heart pumping function (measured as left ventricular ejection fraction, or LVEF) is at or below 45%, or people aged 50 and over or those with significant heart rhythm problems, who will need to undergo a cardiac evaluation before being considered.
• People whose blood oxygen level measured by a simple fingertip sensor is at or below 92% while breathing normal room air (though re-evaluation may be possible if the cause improves).
• People whose cancer cells show a specific change or loss in the HLA-A*02:01 immune marker that would affect how the treatment works.
• People who are currently breastfeeding, as the experimental treatment could carry unknown risks to a nursing infant.
• People with a condition that weakens the immune system, such as HIV or a genetic immune deficiency disorder.
• People currently taking immune-suppressing medications, including corticosteroids, unless they meet specific exceptions outlined by the trial team.
• People with certain serious autoimmune diseases, such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or lupus. People with milder autoimmune conditions such as an underactive thyroid or vitiligo may still be considered.
• People with another current or prior cancer whose history or treatment is likely to interfere with this trial's safety or results (certain low-risk cancers, such as skin cancers treated with local removal or low-grade prostate cancer, may still be eligible — confirm with trial site).
• People who have received a live vaccine within 30 days before enrolling.
• People currently participating in another clinical trial involving an experimental treatment.
• People for whom the principal investigator determines that participation would not be in their best interest or could put them or the trial data at risk.

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