Early Phase 1 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:

• Adults between 18 and 75 years old
• People who have been confirmed by tissue testing to have primary, returned, or spread breast cancer
• People whose doctors estimate they have a life expectancy of more than 3 months
• People who are well enough to carry out some daily activities (based on standard medical scoring tools used by the trial team)
• People whose standard treatment options have stopped working, or for whom no standard treatments exist
• People who have a tumour area that can be safely biopsied or removed, or who have malignant fluid in the body from which immune cells can be collected
• People who have at least one tumour that can be measured to track changes
• People whose blood test results taken within 7 days before joining show that white blood cells, neutrophils, lymphocytes, platelets, haemoglobin, clotting measures, kidney function, liver enzymes, and bilirubin all meet the specific levels required by the trial (confirm with trial site for exact values)
• People who have no medical reasons 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 any cancer-targeting treatments — including radiation, chemotherapy, or 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 daily steroid medication (such as prednisone) at doses above 15mg per day, or who have autoimmune conditions requiring immune-suppressing treatment
• People with significantly reduced lung function based on breathing tests (confirm specific thresholds with trial site)
• People with serious heart conditions, including severe heart failure, significantly low blood pressure, uncontrolled coronary artery disease, very low heart pumping function, or serious 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 severe physical or mental health conditions
• People who have an active infection throughout the body that requires treatment, or who have evidence of infection in blood tests or scans
• People who have received other medicines, biological therapies, chemotherapy, or radiotherapy within the past month, or who are currently receiving them
• People who have a known allergy to substances similar to those used in cell-based therapies
• People who have previously received immunotherapy and experienced serious immune-related side effects rated above Level 3
• People who still have unresolved side effects from previous cancer treatments that have not returned to a mild level (as rated by a standard medical scale), with the exception of hair loss
• People who are pregnant or breastfeeding
• People who have previously had an organ transplant, a stem cell transplant using donor cells, or ongoing kidney replacement therapy such as dialysis
• People whom the trial researchers consider to have other serious health conditions or other reasons that make participation in this trial unsuitable

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