Phase 1 Oesophageal 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:

• Adults aged 18 or older
• People who have been diagnosed with esophageal or gastroesophageal junction (EG) adenocarcinoma, confirmed by a tissue test (pathology)
• People whose cancer has spread to other parts of the body (metastatic) or has come back after previous treatment (recurrent)
• People in reasonably good general health, able to carry out daily activities with minor limitations (confirmed by a doctor's assessment score of 0 or 1)
• People with a life expectancy of at least 4 months
• People whose tumor has been tested and shows that more than 25% of the cancer cells carry a protein called mesothelin (MSLN), as confirmed by a laboratory test on tissue samples (tissue from up to 2 years before joining the trial may be acceptable; if no suitable stored tissue is available, a new biopsy may be needed)
• People with Stage IV cancer that has spread to the lining of the abdomen (peritoneal involvement), confirmed by scans, fluid samples, or a keyhole surgical procedure
• People whose cancer has continued to grow or who could not tolerate at least one previous treatment given for metastatic disease; people whose cancer came back within 6 months of finishing a course of treatment aimed at cure are also eligible
• People with HER2-positive cancer who have received at least one treatment specifically targeting HER2
• People who have at least one area of cancer that can be measured or assessed on scans, with scan results obtained within the required timeframes set by the trial
• People whose previous cancer treatments have been completed within the timeframes required by the trial before each stage of treatment
• People whose blood test results fall within the ranges required by the trial (including counts for white blood cells, red blood cells, platelets, and measures of liver and kidney function) — specific values to be confirmed with the trial site
• People who have tested negative for certain infectious diseases, including hepatitis B, hepatitis C, HIV, HTLV, and syphilis (people with a past hepatitis B or C infection may still be eligible if the virus is no longer detectable in their blood — confirm with trial site)
• People who have recovered from serious side effects of any previous cancer treatment, with only minor or no remaining side effects (nerve-related side effects and hair loss are exceptions)
• Female participants of childbearing potential who have a negative pregnancy test at the required points in the trial and who are willing to use reliable contraception for at least 12 months after the cell treatment

Who may not be able to join:

• People who are pregnant or breastfeeding
• People with an active HIV infection, active hepatitis B, or active hepatitis C infection
• People currently receiving treatment for another active cancer (exceptions may apply for certain low-risk skin cancers, cancers diagnosed more than 3 years ago that are considered cured, or people continuing certain maintenance treatments such as hormonal therapy — confirm with trial site)
• People with a known blood cancer that required treatment in the past 5 years, or any history of a lymph system cancer
• People who have previously received CAR T cell therapy or any other cell-based therapy
• People who have previously received treatment specifically targeting the mesothelin protein
• People who have had major abdominal surgery (involving removal of part of the digestive tract or an organ) within 28 days before joining the trial (diagnostic keyhole surgery is not an exclusion)
• People with untreated or currently active cancer that has spread to the brain or spinal cord; people with previously treated brain metastases may be eligible if specific criteria are met — confirm with trial site
• People with an active autoimmune disease that required systemic medical treatment within the past year (hormone replacement therapies such as thyroid or insulin are not considered a disqualifying systemic treatment)
• People currently taking daily steroid medication (such as prednisone) at a dose of 10 mg or more per day, or taking other medications that suppress or modify the immune system
• People with serious heart conditions, including advanced heart failure, a heart attack within the past 6 months, a history of heart muscle inflammation (myocarditis), uncontrolled abnormal heart rhythms or chest pain, or reduced heart pumping function (ejection fraction of 40% or less)
• People with active lung inflammation (pneumonitis or interstitial lung disease), or a history of this condition that required treatment with steroids
• People whose blood oxygen level is below 90% while breathing normal room air at the time of screening
• People with an active infection that is being treated with antibiotics within 7 days before the cell collection procedure (treatment may be delayed to allow recovery — confirm with trial site)
• People who have received a live or weakened live vaccine within 8 weeks before the planned chemotherapy stage of the trial
• People with any other medical condition — for example, a fever above 38.0°C — that the trial doctor believes could interfere with safe participation
• People who the study team considers unlikely to be able to follow the close monitoring and follow-up required by the trial

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