Phase 1 Ovarian 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:

• Your blood has tested positive for a specific genetic marker called HLA-A*02:01
• Your tumour produces a protein called MAGE-A4 at a high enough level (confirmed by testing)
• You have been diagnosed with one of the following cancers that cannot be removed by surgery and has spread: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, or head and neck cancer
• There are no standard treatments available or suitable for you, or you are unable to tolerate or have chosen not to have standard treatment
• Scans have confirmed your cancer has continued to grow during or within 6 months after your most recent treatment
• You have had at least 2 previous cancer treatments (or at least 1 if you have synovial sarcoma)
• Your cancer can be measured on scans using standard criteria
• You are able to carry out daily activities with little or no restriction (confirmed with trial site), have not gotten worse in the last 2 weeks, and are expected to live more than 3 months
• If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, must have a negative pregnancy test, and must agree to use effective contraception

Who may not be able to join:

• You have previously had any cell therapy or gene therapy
• You have taken part in another experimental treatment study within the last 4 weeks before a specific preparatory treatment called lymphodepletion
• You have recently received certain cancer treatments, such as immunotherapy drugs (for example, PD-1 blockers) or biological therapies (such as monoclonal antibodies), within the last 4 weeks before lymphodepletion
• You still have significant side effects (grade 2 or above) from a previous cancer treatment that could interfere with this study
• You have had another active cancer (other than the one being studied) in the past 3 years, except for certain minor skin cancers or early-stage cervical conditions that were fully treated
• You have an active autoimmune disease or any condition that requires immune-suppressing medication or steroids (routine replacement therapy, skin creams, or inhalers are generally acceptable)
• You have a serious condition affecting your brain or nervous system
• You have had a serious heart-related event — such as a heart attack, heart surgery, significant heart rhythm problems, or heart failure — within the last 6 months
• You have an active infection requiring intravenous (drip) antibiotics, antifungal, or antiviral medication within 7 days before lymphodepletion
• You have received or are planned to receive a live vaccine within 6 weeks before the start of lymphodepletion
• You have a serious or uncontrolled medical condition (such as severe lung disease, severe Parkinson's disease, or active bowel inflammation) or a serious mental health condition that could interfere with taking part
• You have an active bleeding problem, are on blood-thinning medication, or have had major surgery within 28 days before lymphodepletion (minor procedures such as biopsies are generally acceptable)
• You have a significantly weakened immune system
• You have a known serious liver or bile duct problem, or an active hepatitis B or hepatitis C infection
• You have any medical, psychological, or social issue — including drug or alcohol use — that would make it difficult to follow the study's requirements
• You have had an allergic reaction to drugs similar to cyclophosphamide or fludarabine, which are used in this study
• Your heart's electrical activity (measured by an ECG) shows a reading above a certain level — over 450 milliseconds for men or over 470 milliseconds for women (confirm with trial site)
• You have a medical condition, such as being on blood thinners that cannot be safely stopped, that makes a biopsy unsuitable or risky in the investigator's opinion
• You have a known allergy or intolerance to local anaesthetic
• You have recently received immune-suppressing medication (confirm timeframe with trial site)
• You still have significant side effects (grade 2 or above) from previous treatment that could interfere with the study (this criterion appears twice in the original document — confirm details with trial site)

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