Phase 1 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 head and neck cancer (confirmed by a tissue test), where the cancer is either advanced and cannot be surgically removed, or has spread to up to 5 sites in the body, and has come back or gotten worse after standard treatments, has no standard treatments available, or where standard treatments are no longer working — including people who have declined such treatments.
• People whose tumour shows a protein called TROP2 at a moderate or high level (rated 2+ or 3+), as measured by a specific laboratory test at the study institution.
• People who are at least 18 years old.
• People who are generally well enough to carry out normal daily activities with little or no limitation (performance status 0 or 1 on a standard medical scale).
• People whose treating doctor estimates they are likely to live for at least 3 more months.
• Women who are not able to become pregnant, or women who can become pregnant and agree to use approved contraception during the study and for 6 months after receiving the study cell treatment — and who have a negative pregnancy test before starting treatment.
• Men who agree to use approved contraception during the study and for 6 months after receiving the study cell treatment.
• People who have measurable cancer that can be tracked and assessed using standard imaging criteria.
• People whose blood, kidney, liver, and clotting results fall within acceptable ranges on tests done within 10 days before treatment begins.
• People whose heart pumps with at least 50% efficiency, as measured by a standard heart test.
• People who have no or only mild shortness of breath (Grade 0 or 1) and whose blood oxygen level is above 92% while breathing normal room air.
• People who have previously received TROP2-targeted therapy — this is permitted.
• People who are willing to have required blood draws and tissue biopsies as part of the study.
• People who are willing to sign consent for long-term follow-up as part of a separate study protocol.
• People who are willing to remain within approximately a 2-hour drive (around 100 miles) of the study site for the first 4 weeks after receiving the study cell treatment.
• People with a history of another cancer, where that cancer or its treatment is not expected to interfere with this study's safety or results.
• People with known heart disease or a history of treatment with medicines that can affect the heart, whose heart function is assessed as Class 2B or better on a standard heart classification scale.
• People who are able to understand and willing to sign a written consent form.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 6 months after receiving the study cell treatment.
• People who have received cancer treatment within the past 2 weeks (or within 5 half-lives of the drug, whichever is shorter), or within the past 3 weeks if the treatment was a type of antibody-based therapy.
• People who have not yet recovered from side effects of previous cancer treatments (side effects must have improved to a mild or baseline level before joining).
• People who received radiation therapy within 2 weeks before starting the preparatory chemotherapy and still need steroid medicines as a result, or who experienced lung inflammation from that radiation.
• People who have received a live vaccine within 6 weeks before the study cell treatment, or who would need one within 24 months after — examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, and some typhoid vaccines (standard flu shots and COVID-19 injections are generally allowed, but nasal spray flu vaccines are not).
• People who have previously received a type of immune cell therapy known as CAR T-cell, CAR NK-cell, or other genetically modified T or NK cell treatment.
• People who have an immune system disorder, or who are taking ongoing steroid medicines at doses above the equivalent of 10 mg of prednisone per day.
• People with a history of a second cancer, unless treatment for that cancer was completed at least 2 years ago with no signs of it returning — note that certain skin cancers and some early-stage cancers that were fully removed may not require this waiting period (confirm with trial site).
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord — although people whose brain metastases were previously treated and have been stable without steroids for at least 2 weeks may be considered.
• People with an active autoimmune disease that has needed systemic treatment in the past 2 years — hormone or other replacement therapies for conditions like thyroid or adrenal problems are generally allowed.
• People with a history of a lung condition called interstitial lung disease that required steroid treatment, or who currently have lung inflammation.
• People with an active infection that requires treatment through the bloodstream (such as intravenous antibiotics).
• People with a known HIV infection.
• People with known active or ongoing hepatitis B or hepatitis C infection.
• People with a known history of active tuberculosis.
• People with any medical condition, ongoing treatment, or lab result that, in the treating doctor's opinion, could interfere with the study results or make participation unsafe.
• People with mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who have received an organ or tissue transplant from another person.
• People who have had a significant heart problem within the past 12 months, such as severe heart failure, unstable chest pain, heart attack, stroke, or a heart rhythm problem that caused instability — note that heart rhythm problems that are well controlled with medication are generally permitted.
• People whose heart's electrical activity (measured by a specific interval on a heart tracing) is prolonged beyond a certain threshold (confirm with trial site).
• People with bleeding disorders or clotting disorders that put them at serious risk of heavy bleeding — note that people with known blood clots in the veins or lungs who are on appropriate blood-thinning treatment are generally permitted.
• People with a history of severe mouth or throat sores (Grade 3 or higher) from previous treatment.
• People with a known serious allergy to medicines similar to cyclophosphamide or fludarabine, which are used in this study.

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