Phase 1 Colorectal 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 aged 18 to 75 years (any gender) with an advanced gastrointestinal tumour confirmed by a tissue test, specifically those with metastatic colorectal cancer where at least two prior standard treatment lines have stopped working or could not be tolerated due to serious side effects such as severe vomiting, diarrhoea, stomach pain, or low blood counts
• People who have at least one tumour that can be measured on a scan, according to standard measurement rules (RECIST 1.1)
• People whose tumour tissue sample (taken within the last two years) has tested positive for a protein called GUCY2C, detected by a laboratory staining method
• People whose life expectancy is estimated to be more than three months
• People with a physical fitness score of 0 or 1 on the ECOG scale, meaning they are either fully active or have some limits on heavy physical activity but can walk and do light work
• Women who could become pregnant must have a negative blood pregnancy test before the trial starts, and must agree to use effective contraception throughout the trial and up to the last follow-up visit; male participants whose partners could become pregnant must also agree to use effective contraception for the same period
• People whose blood test results meet specific minimum levels: haemoglobin at least 90 g/L; neutrophil count at least 1.5 × 10⁹/L; platelet count at least 75 × 10⁹/L; lymphocyte count at least 0.6 × 10⁹/L; lymphocytes making up at least 10% of white blood cells; kidney filtration rate at least 60 ml/min; liver enzyme levels (ALT and AST) no more than 2.5 times the upper limit of normal, and total bilirubin no more than 1.5 times the upper limit of normal (with some flexibility if liver involvement from the cancer explains higher levels); blood protein (albumin) at least 3.0 g/dL; and blood clotting time not prolonged by more than 4 seconds
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%, with a normal heart tracing (ECG) or an abnormal one that the doctor judges does not need treatment
• People whose blood oxygen level is above 92% without needing supplemental oxygen
• People who have adequate veins for blood cell collection, or who already have a central venous line in place
• People who voluntarily agree to take part and sign a consent form

Who may not be able to join:

• People who have cancer that has spread to the brain
• People who have previously had an organ transplant or are waiting for one
• People still experiencing side effects from previous treatments that have not settled back to a mild level (grade 1 or lower), unless the trial doctor judges these to be not medically significant
• People who have a build-up of fluid (for example, around the lungs, in the abdomen, or around the heart) that is causing pressure symptoms and cannot be controlled with treatment
• People who have had an autoimmune disease requiring whole-body immune-suppressing treatment (such as Crohn's disease, rheumatoid arthritis, or lupus) within the two years before screening
• People with chronic obstructive pulmonary disease (COPD), scarring or inflammation of the lungs (interstitial lung disease), or other significant lung function problems
• People who have received certain medications or treatments within specific time windows before the cell collection procedure, including: high-dose steroid tablets within 7 days (topical or inhaled steroids are allowed); chemotherapy within 1 week (or within 3 half-lives for oral chemotherapy); bone marrow stimulating drugs within 5 days; another experimental study drug within 4 weeks (unless the disease has progressed and at least 5 half-lives have passed); local treatments such as radiotherapy, ablation, or other targeted procedures within 4 weeks; major surgery or serious injury within 4 weeks, or expected major surgery during the study; or targeted drugs such as regorafenib or furaquintinib within 1 week
• People who have previously been treated with a therapy that targets the GUCY2C protein, unless a follow-up test still shows the GUCY2C protein is present
• People who have previously received any other cell therapy or gene-modified cell therapy, such as CAR-T or TCR-T therapy
• People who have previously received immune checkpoint therapies (such as anti-PD-1 or anti-PD-L1 drugs) unless at least 5 half-lives of that drug have passed before the planned cell infusion
• People with a history of significant brain or nervous system conditions, such as epilepsy, stroke, brain injury, dementia, Parkinson's disease, or serious psychiatric disorders
• People with ongoing or active infections requiring systemic treatment, or a history of symptomatic viral infections not fully resolved — including active hepatitis B (with detectable virus in the blood), active hepatitis C (with detectable virus in the blood), HIV infection, or syphilis
• People with active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection, based on specific blood test results (confirm with trial site)
• People who have received a live vaccine within 6 weeks before screening
• People with significant heart problems, including: a specific type of abnormal heart rhythm (long QTc syndrome or QTc interval above 480 ms); certain types of heart conduction blocks; serious uncontrolled irregular heartbeat requiring medication; a history of heart failure rated as class 3 or above on the NYHA scale with a heart pumping function below 50% in the past 6 months; significant heart valve disease; or a heart attack, stenting, unstable chest pain, serious pericardial disease, or other significant heart condition within the past 6 months
• People who need anticoagulation (blood-thinning) therapy
• People who need long-term use of medications that affect blood clotting, such as aspirin or warfarin
• People who have had a blood clot in a deep vein or in the lungs with symptoms within the 6 months before screening
• People who have had or currently have another cancer within the past 5 years, with the exception of certain early-stage or non-invasive cancers (cervical cancer in situ, basal cell skin cancer, or ductal carcinoma in situ of the breast)
• People with an active infection requiring intravenous antibiotics or antifungal treatment that cannot be controlled (some minor infections such as simple urinary tract infections or throat infections may be considered if the trial doctor believes they can be treated effectively — confirm with trial site)
• People who have a blockage in their digestive tract
• People considered at high risk of bleeding or bowel perforation
• People already taking part in another interventional clinical trial at the same time
• People who are unwilling or unable to follow the procedures required by the study, as judged by the trial doctor

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