Phase 1 Pancreatic 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 are willing and able to sign a consent form agreeing to participate, including agreeing to tests for certain genetic markers
• Adults between 18 and 75 years old (inclusive), of any gender
• People who have been diagnosed with pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) confirmed through laboratory testing of tissue or cells
• People whose cancer cannot be removed by surgery and has either spread or is locally advanced, and whose cancer has continued to grow after receiving standard chemotherapy treatments (such as gemcitabine-based regimens, FOLFIRINOX, or NALIRIFOX), including people whose cancer came back within 6 months of finishing pre- or post-surgery chemotherapy
• People who have at least one tumour that can be measured on a scan, meeting specific size requirements (generally at least 10mm for non-lymph node tumours, or at least 15mm for lymph node tumours)
• People whose tumour has tested positive for a specific gene mutation called KRAS-G12V, and who also carry a specific immune system marker called HLA-A*11:01
• People who are reasonably active and able to carry out basic daily activities, as measured by a standard medical scale (ECOG score of 0 or 1)
• People whose doctors estimate they have a life expectancy of at least 3 months
• People whose blood, liver, kidney, heart, and lung function meet specific minimum levels as measured by laboratory and other tests (the trial site can provide full details of these requirements)
• Women of childbearing age who test negative for pregnancy at the start of the trial and agree to use effective contraception for at least one year after receiving the treatment; male participants whose partners could become pregnant must also agree to use effective barrier contraception and avoid sperm donation for at least one year after treatment

Who may not be able to join:

• People who currently have, or have had within the past 5 years, another cancer that cannot be cured — with exceptions for certain skin cancers, cancers that have not spread beyond where they started, or breast cancer that was successfully treated with no recurrence in the past 3 years
• People who have had an organ transplant at any point
• People with a history of mental health conditions that might affect their ability to follow the study plan or to sign a consent form
• People with a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, or lupus) that require ongoing treatment with drugs that suppress the immune system
• People with high blood pressure that is not well controlled by medication, or who have had serious heart problems (such as heart failure, heart attack, stent placement, or unstable chest pain) within the past year; also people whose heart rhythm test (ECG) shows a measurement called the QTc interval that is too long (over 450ms for males or over 470ms for females)
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms
• People who have a build-up of fluid in the abdomen or around the lungs that needs to be drained, or who have had such drainage within the past 2 weeks (small amounts of fluid that are not causing symptoms may be acceptable — confirm with trial site)
• People who have experienced a bowel obstruction related to their cancer within the past 6 months
• People who have had a central nervous system condition (such as seizures, stroke, bleeding in the brain, dementia, or certain autoimmune brain conditions) within the past 6 months
• People who test positive for HIV, active hepatitis C, active hepatitis B, or syphilis
• People who have an active infection (fungal, bacterial, viral, or other) that is not under control or requires intravenous (IV) antibiotics or antifungals
• People who have a significant tendency to bleed, such as active gastrointestinal bleeding or a blood clotting disorder
• People who have had a deep vein blood clot requiring treatment within the past 6 months, unless the treating doctor considers the risk to now be acceptably low
• People who have interstitial lung disease (such as lung scarring or inflammation) or other significant lung conditions identified at screening
• People who have received certain white blood cell-stimulating medications (G-CSF or GM-CSF) within 2 weeks before a specific blood collection procedure used in this trial
• People who have received gene therapy or other cell-based therapies within the past 6 months
• People who are currently in another clinical trial, or who received a study drug in another trial within the past 28 days (or within 5 half-lives of that drug, whichever is longer)
• People who are unlikely to be able to follow the study schedule or requirements due to personal, family, social, or geographic reasons
• People who have a known reason they cannot receive the medications used in this study
• People who require ongoing treatment with corticosteroids (such as dexamethasone at higher doses) or other immune-suppressing drugs during the study period
• Women who are currently breastfeeding and are unwilling to stop
• People who the treating doctor considers unsuitable for the trial for any other reason

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