Early Phase 1 Melanoma 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 18 to 75 years
• People who have been diagnosed with primary, relapsed, or metastatic melanoma confirmed by tissue testing
• People whose life expectancy is more than 3 months
• People who have a reasonable level of general physical functioning (as assessed by a doctor using standard scoring tools)
• People whose melanoma has not responded to standard treatments, or for whom no standard treatments are available
• People who have a tumour area that a doctor can safely biopsy or remove, or a body fluid collection (such as fluid around the lungs) from which immune cells can be extracted
• 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) meet all of the following levels: sufficient white blood cells, neutrophils, lymphocytes, and platelets; haemoglobin not too low; blood clotting measures within acceptable ranges; kidney function within acceptable limits; liver enzyme levels within acceptable ranges; and total bilirubin within acceptable range
• People for whom a doctor considers biopsy or surgery to be safe
• People of childbearing potential who are willing to use highly effective contraception from the time of consent and for one year after completing a specific treatment phase of the trial
• People who have stopped all cancer-targeting therapies — including radiotherapy, chemotherapy, and biological treatments — 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 other study requirements

Who may not be able to join:

• People who need regular steroid medication (such as prednisone) at a daily dose greater than 15 mg, or who have an autoimmune condition requiring immune-modifying treatment
• People with significantly reduced lung function, based on specific breathing test measurements
• People with serious heart conditions, including severe heart failure, significantly low blood pressure, uncontrolled coronary artery disease, very low heart pumping function, or serious abnormal heart rhythms 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 a positive blood culture or imaging showing signs of infection
• People who have received other medicines, biological therapies, chemotherapy, or radiotherapy within the past month, or who are currently receiving these treatments
• People with a history of allergic reactions to substances similar to those used in cell-based therapies
• People who have previously received immunotherapy and experienced a serious immune-related side effect rated at Level 3 or higher
• People who still have side effects from previous cancer treatments that have not returned to a mild or resolved level (with some exceptions, such as hair loss, at the investigator's discretion)
• People who are pregnant or breastfeeding
• People who have had an organ transplant, a stem cell transplant using donor cells, or kidney dialysis
• People whom the research team considers 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.