Phase 3 Stomach 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:

• Adults aged 18 or older, of any gender
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus that cannot be surgically removed, has spread, and has not responded to at least two prior treatment regimens (or one prior regimen if it included three specific drug types — taxane or anthracycline, platinum, and fluorouracil — or if the cancer returned within 6 months of completing pre- or post-surgery treatment)
• People whose cancer shows high levels of a protein called CLDN18.2, confirmed by a central laboratory test on tumour tissue (from a stored or newly collected sample); if prior CLDN18.2-targeted therapy was received, a fresh tissue sample collected after that treatment is required
• People whose doctors estimate they are likely to survive at least 12 weeks
• People who have at least one measurable or assessable tumour that is no larger than 5 cm at its longest point (or shortest point if it is a lymph node)
• People whose general physical fitness is rated 0 or 1 on the ECOG scale, meaning they are fully active or have mild limitations but are able to care for themselves (confirm with trial site)
• People whose blood, liver, kidney, and pancreatic function test results fall within the acceptable ranges set by the trial (confirm with trial site for specific values)
• People whose side effects from previous cancer treatments have mostly resolved to mild or no symptoms before joining
• People who are willing to use highly effective contraception (such as an intrauterine device or condoms) from the time of signing consent until 12 months after receiving the cell treatment — this applies to women who could become pregnant, and to men whose partners could become pregnant
• People who are willing and able to sign a consent form and follow the study schedule, including treatment visits, lab tests, and follow-up appointments

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People who test positive for HIV, active hepatitis B, active hepatitis C, syphilis, Epstein-Barr virus (recent infection), cytomegalovirus (recent infection), HTLV, or active COVID-19 that has not cleared within 7 days
• People whose cancer tests positive for a protein called HER2 at certain defined levels (IHC 3+, or IHC 2+ with FISH+)
• People with a serious active infection that is not well controlled
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled
• People with widespread or extensive spread of cancer to the lungs, liver, or bones
• People whose blood oxygen level is 95% or below without supplemental oxygen
• People with other serious lung conditions such as pulmonary embolism, chronic obstructive pulmonary disease, or poorly controlled interstitial lung disease
• People whose tumour is judged by doctors to carry a high risk of bleeding or perforation based on imaging or endoscopy findings
• People with a history of or current brain or nervous system conditions such as epilepsy, stroke, dementia, or autoimmune conditions affecting the brain; or people with cancer that has spread to the brain or surrounding membranes and is not well controlled
• People with unstable or poorly controlled heart disease, high blood pressure that remains at 160/100 mmHg or above despite medication, or blood sugar that remains very high despite standard treatment
• People with certain heart-related findings or events in the 6 months before treatment, including low heart pumping function, recent heart attack, unstable chest pain, prior heart bypass or stent procedure, use of a pacemaker, or certain abnormal heart rhythm readings
• People with significant bleeding disorders or blood clotting problems, recent internal bleeding, tumours near major blood vessels with high bleeding risk, active stomach or intestinal bleeding, a blood clot event in the past 6 months, significant coughing of blood in the past month, major surgery or trauma in the past month, conditions like haemophilia, or current use of certain blood-thinning or antiplatelet medications
• People who have used high-dose steroid tablets (more than the equivalent of 15 mg per day of prednisone for more than 3 days) in the 2 weeks before the blood collection procedure (apheresis), not including inhaled steroids
• People who need ongoing steroid or immune-suppressing medications, or who have an active autoimmune disease or one likely to return (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease) — some exceptions apply (confirm with trial site)
• People with a current or previous different type of cancer, with some exceptions for fully treated skin cancers, cervical or breast cancer in remission for at least 3 years, or other cancers fully removed and in complete remission for 5 or more years
• People who have previously received any gene therapy, including CAR-T or TCR-T cell therapy
• People who have received other cancer treatments (chemotherapy, targeted therapy, immunotherapy, biological therapy, hormonal therapy, or certain traditional Chinese medicines with anti-tumour indications) within timeframes too close to the planned treatment in this study (confirm with trial site for specific timing)
• People with a history of severe allergic reactions such as anaphylactic shock
• People with severe mental health conditions
• People with a new uncontrolled heart rhythm problem, very low blood pressure requiring medication, or a serious infection requiring intravenous antibiotics at the time of enrolment (the investigator will assess this)
• People who are currently taking part in another interventional clinical trial or have used a study drug within 1 month before the planned treatment infusion
• People who received or plan to receive a live attenuated vaccine within 4 weeks before the blood collection procedure or during the study
• People with a blockage in the bowel or bile duct, as judged by the investigator
• People with any other serious or uncontrolled medical condition that the investigator considers unsuitable for participation
• People the investigator believes are unable or unwilling to follow the study requirements

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