Phase 1 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the 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 voluntarily agreed to sign a consent form to take part in the study
• People aged 18 to 70 years old (inclusive), of any gender
• People who have been diagnosed with advanced pancreatic cancer or colorectal cancer, whose cancer has not responded to — or who could not tolerate — at least two rounds of standard treatment (including chemotherapy, surgery followed by chemotherapy, or treatment given before surgery)
• People whose cancer has at least one area that can be measured on a scan, according to standard medical criteria called RECIST 1.1
• People whose tumour tissue or blood has tested positive for specific gene changes called KRAS-G12V or G12D mutations, and who also carry certain immune system protein types (HLA-A*11, C*01:02, or C*08:02)
• People with a general health and activity level rated at 2 or below on the ECOG scale — a standard medical measure of how much a person's illness affects their daily activities (confirm with trial site)
• People with a life expectancy of at least 3 months
• People whose blood counts meet minimum levels: neutrophils (a type of immune cell) at or above 1×10⁹/L, platelets at or above 50×10⁹/L, haemoglobin above 90 g/dL, and lymphocytes (another type of immune cell) at or above 0.5×10⁹/L
• People whose liver, kidney, and heart function meet specific minimum standards, including liver enzyme levels within acceptable ranges, kidney function above a set threshold, bilirubin levels within range, heart pumping function of at least 50% with no significant fluid around the heart, no major abnormalities on a heart tracing (ECG), and blood oxygen levels above 92% while breathing normal indoor air
• Women who could become pregnant must have a negative blood pregnancy test at screening and at the start of the study, and must agree to use effective contraception for at least one year after receiving the treatment; male participants whose partners could become pregnant must agree to use barrier contraception methods and avoid donating sperm for at least one year after treatment, or until tests confirm the treatment cells are no longer present — whichever is later

Who may not be able to join:

• People who have or have had another type of cancer, with exceptions for certain skin cancers that have been clear for more than 5 years, or certain early-stage cancers of the cervix, bladder, or breast
• People with a history of mental health conditions that may affect their ability to follow the study requirements or to sign the consent form
• People with high blood pressure that is not well controlled by medication (above 160/90 mmHg), or who have had serious heart problems — such as severe heart failure, heart attack, a heart procedure, or unstable chest pain — within the past year; or people whose heart electrical reading (ECG) shows a QTc interval above 450 ms (males) or 470 ms (females)
• People who have an internal tube or drain in place (such as a kidney drain, bladder catheter, bile duct drain, or fluid drainage tube from around the lungs, abdomen, or heart), unless it is a standard central venous line used for treatment
• People with a history of, or current, brain or nervous system conditions such as epilepsy, stroke, dementia, cerebellar disease, or autoimmune conditions affecting the brain or spinal cord
• People who test positive for HIV, active Hepatitis C, active Hepatitis B, or active syphilis
• People who have an active infection (fungal, bacterial, viral, or other) that is not under control or requires treatment through a drip (intravenous antibiotics or antifungals)
• People with a significant tendency to bleed, such as active bleeding in the digestive system or blood clotting problems
• People with a history of serious allergic reactions or a constitution that makes them highly prone to severe allergies
• People who have an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has required ongoing immune-suppressing or disease-modifying medication in the past 2 years
• People with lung conditions such as inflammation of the lung tissue or pulmonary fibrosis, or significant breathing problems identified at screening
• People who have had an organ transplant
• People who have received certain white blood cell boosting injections (G-CSF or GM-CSF) within 2 weeks before the blood collection procedure (leukapheresis)
• People who have received gene therapy or cell therapy targeting the same pathway within the past 6 months
• People who have taken part in another clinical trial within 4 weeks before signing the consent form, or whose last trial drug has not yet cleared from their body based on standard timing guidelines — whichever period is longer
• People who, due to personal, family, social, or geographic reasons, are unlikely to be able to follow the study requirements and attend all follow-up appointments
• People who have a known reason they cannot receive cyclophosphamide, fludarabine, IL-2, or other medications involved in the study
• People who require treatment with steroid medications at or above a certain dose, or other immune-suppressing drugs, within 12 weeks of starting the study treatment
• Women who are breastfeeding and are not willing to stop during the study
• People who the trial investigator considers unsuitable for any other reason

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