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:

• People who have been diagnosed with a specific type of recurring ovarian cancer (high grade serous, high grade endometrioid, or clear cell ovarian carcinoma), confirmed through a tissue or cell sample.
• People whose cancer can be measured on scans using standard medical guidelines (called RECIST 1.1).
• People who have received at least one round of prior cancer treatment and whose cancer has stopped responding to platinum-based chemotherapy, or who cannot tolerate it — and, if a BRCA1 or BRCA2 gene mutation is present, people who have also previously received a type of targeted therapy called a PARP inhibitor.
• People aged 18 to 84 years old.
• People who are generally well enough to carry out normal daily activities with little or no limitation (known as ECOG performance status 0 or 1).
• People whose blood counts, liver function, kidney function, oxygen levels, and heart function meet specific minimum levels as determined by lab tests (confirm with trial site for exact values).
• People who have or have had another cancer, as long as that cancer and its treatment are unlikely to interfere with this trial's safety assessments (confirm with trial site).
• People with a history of heart disease or prior treatment with heart-affecting drugs, provided a doctor's assessment places their heart function at a certain level or better (New York Heart Association Class 2B or better).
• People whose doctor considers them fit enough to undergo a small procedure to place a port in the abdomen for the cell infusion treatment.
• People who are willing and able to read and sign a consent form agreeing to take part.
• People of childbearing potential, and men, who agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) throughout the trial period, due to unknown risks of the study treatments to an unborn baby.

Who may not be able to join:

• People who have received anti-cancer chemotherapy or other experimental treatments within two weeks before the cell infusion (or six weeks for certain specific chemotherapy types), or immunotherapy within six weeks before, or whose side effects from prior treatments have not yet resolved.
• People who have had a bowel blockage in the past three months, are considered at high risk of a bowel blockage, or who currently need nutrition through a drip or are dependent on intravenous fluids.
• People who are currently enrolled in another experimental treatment trial.
• People who have received a transplanted organ from another person.
• People with another active cancer that is growing or currently being treated, or a history of another cancer within the past two years — with some exceptions such as certain skin cancers, early-stage bladder cancer, cervical pre-cancer, or cancers where the person has been free of disease for more than one year after treatment intended to cure it.
• People who have had a severe or life-threatening allergic reaction to substances similar to those used in this trial (including the study cell therapy or IL-2).
• People who previously received immune checkpoint therapy and had serious immune-related side effects that led to permanently stopping that treatment, or who needed prolonged or intensive steroid treatment to manage those side effects — except for hormone-related side effects that are now well controlled with replacement therapy.
• People with certain autoimmune diseases, including inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), rheumatoid arthritis, lupus, scleroderma, autoimmune vasculitis, or autoimmune nerve conditions such as Guillain-Barré syndrome or myasthenia gravis. (Note: people with Hashimoto's thyroiditis are not excluded.)
• People taking ongoing steroid medication at a dose higher than 10mg of prednisone (or equivalent) daily for at least four weeks before the cell infusion.
• People with uncontrolled ongoing illness, including active infections, unstable heart conditions, uncontrolled heart rhythm problems, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant, due to unknown risks of the study treatments to a developing baby. People who are breastfeeding would need to stop breastfeeding to participate in this trial.
• People who are HIV-positive, due to risks of dangerous drug interactions and increased infection risk.
• People with active, uncontrolled hepatitis B or C infection, due to risk of serious liver-related complications. Also, people with a history of non-infectious lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease).
• People who have received a live vaccine within 30 days before the start of treatment.
• People who have had a severe allergic reaction to treatments made using mouse-based antibodies or to iron dextran, as the study cell product contains similar materials.
• People who have a history of a moderate or severe condition where their red blood cells were broken down by the immune system (Grade 2 or higher haemolytic anaemia) from any cause.

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