Phase 1 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:

• You must be at least 18 years old.
• Your cancer must have spread to other parts of the body (metastatic), and at least 10% of your tumor cells must test positive for a protein called KK-LC-1 on a special lab test — the trial is currently focusing on stomach cancer, non-small cell lung cancer, triple-negative breast cancer, and cervical cancer.
• You must have a specific genetic marker called HLA-A*01:01, confirmed by a blood test.
• Your cancer must be measurable on scans using standard criteria.
• You must have already received standard treatments for your cancer type, or those treatments must have been considered and found unsuitable for you (with documentation explaining why).
• If you have up to 3 brain tumors that have already been treated with surgery or targeted radiation, you may still be eligible — treated areas must have been stable for at least one month.
• You must be in reasonably good general health, able to carry out daily activities with little or no limitation (confirmed by a standard health scoring tool).
• Women under 55, or any woman who has had a menstrual period in the last 12 months, must have a negative pregnancy test (not required if you have had both ovaries or your uterus removed).
• Both men and women who could potentially have children must agree to use reliable birth control during the study and for 12 months after treatment.
• Your blood counts and organ function (including white blood cells, red blood cells, platelets, liver, kidneys, and blood clotting) must meet certain minimum levels confirmed by blood tests.
• You must test negative for HIV, active Hepatitis B, and active Hepatitis C.
• At least four weeks must have passed since your last cancer treatment, and any side effects from previous treatments must have mostly resolved before starting this trial.
• You must agree to participate in two additional linked studies — one for long-term follow-up of gene therapy and one for collection of biological samples.

Who may not be able to join:

• You are currently enrolled in another clinical trial using an investigational treatment.
• You have had a severe allergic reaction to substances similar to those used in this trial.
• You have a history of heart bypass surgery or symptoms of reduced blood flow to the heart, unless a heart stress test comes back normal.
• Your heart pumping function (ejection fraction) is 45% or below — certain people (those aged 50 or older, or those with specific heart rhythm problems) will need to have this checked.
• Your blood oxygen level is 92% or below while breathing normal room air.
• You have an uncontrolled serious illness at the time of treatment, such as an active infection, unstable heart condition, or a mental health or personal situation that would make it hard to follow the study requirements.
• You are currently breastfeeding.
• You have a condition that weakens your immune system, such as HIV or a rare inherited immune deficiency (such as Severe Combined Immunodeficiency Disease).
• You are currently taking immune-suppressing medications, including steroids, unless specific exceptions apply (confirm with trial site).
• Testing shows that your HLA-A*01:01 genetic marker is damaged, lost, or otherwise not functioning properly.
• You have a serious autoimmune disease that is currently active, such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or lupus. (Note: milder autoimmune conditions like thyroid disease or vitiligo do not automatically exclude you; a past diagnosis that is no longer active may also not exclude you — confirm with trial site.)
• You have another current or previous cancer that does not fall into certain limited categories (such as non-invasive skin cancer or very early-stage cancers) — confirm with the trial site whether your specific situation applies.
• You have received a live vaccine within the last 30 days before enrolling.
• The lead researcher decides that joining the trial would not be in your best interest or could put you or the study at risk.

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