Phase 2 Breast 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 aged 16 to 90 years old
• People who have been diagnosed with breast cancer (primary, returned, or spread to other parts of the body), confirmed through a tissue test
• People with a life expectancy of more than 3 months
• People with a reasonable level of general physical functioning, as measured by standard medical scoring tools (confirm with trial site)
• People whose breast cancer has not responded to standard treatments, or for whom no standard treatments are available
• People who have a tumour area that can be biopsied or surgically removed, or a body fluid (such as fluid around the lungs) from which immune cells can be collected
• People who have at least one measurable tumour that can be tracked during the trial
• People whose recent blood test results (taken within 7 days before joining) show that blood cell counts, kidney function, liver function, and clotting measures all fall within the ranges required by the trial (confirm with trial site for specific values)
• People who have no medical reason preventing them from having a biopsy or minor surgery
• People of childbearing potential who are willing to use highly effective contraception from the time of signing consent and for one year after completing a specific part of the treatment
• People who have stopped all cancer-targeting treatments — including radiation, chemotherapy, and biological therapies — at least 28 days before immune cells are collected
• People who are able to understand and sign the consent form
• People who are able to attend follow-up visits and meet the other requirements of the trial

Who may not be able to join:

• People who need regular steroid treatment (such as prednisone) at a daily dose above 15mg, or who have an autoimmune condition requiring immune-suppressing treatment
• People with significantly reduced lung function, based on specific breathing test results (confirm with trial site)
• People with serious heart conditions, including severe heart failure, uncontrolled low blood pressure or coronary artery disease, a heart pumping function below 35%, or significant heart rhythm or electrical conduction problems
• People who have HIV infection or test positive for HIV antibodies, have active hepatitis B or C infection, or have syphilis or test positive for the related antibody
• People with serious physical or mental health conditions
• People who have an active infection throughout the body that requires treatment, or who have positive blood cultures or imaging results showing infection
• People who have received other medicines, biological therapy, chemotherapy, or radiotherapy within the past month, or who are currently receiving these treatments
• People with a known allergy to substances similar to those used in cell-based therapies
• People who have previously received immunotherapy and experienced a severe immune-related side effect rated above Level 3
• People who still have unresolved side effects from previous cancer treatments that are rated above Level 1 (hair loss is generally excluded from this rule)
• People who are pregnant or breastfeeding
• People who have a history of organ transplantation, bone marrow or stem cell transplantation from a donor, or dialysis
• People whom the trial investigators consider unsuitable for any other medical or safety reason

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