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:

• You must be able to understand and willing to sign a written consent form to participate.
• You must agree to allow researchers to use stored tissue samples from a previous tumor biopsy (exceptions may be possible with approval).
• You must be 18 years of age or older.
• You must be well enough to carry out daily activities, with a reasonably good general health status as measured by standard medical scales (confirm with trial site).
• You must have ovarian cancer that has stopped responding to platinum-based chemotherapy, meaning the cancer grew back within 6 months of finishing treatment or kept growing during treatment.
• Your tumor must test positive for a specific protein called TAG72, confirmed by a special lab test at the study center.
• You must have already tried and not responded to — or been unable to tolerate — other standard chemotherapy treatments such as taxanes or liposomal doxorubicin (not all of these must have been tried if the doctor feels this trial is the right next step).
• You must have no known medical reasons preventing you from undergoing a blood cell collection procedure (leukapheresis), or from receiving steroids or a drug called tocilizumab.
• If you are able to become pregnant, you must agree to use reliable birth control during the study and for 3 months after the last treatment.
• Your blood cell counts, liver function, kidney function, and blood clotting levels must meet certain minimum standards as measured by blood tests (confirm with trial site).
• Your heart must be functioning adequately, with no serious abnormalities on a heart tracing (ECG) and a pumping strength of more than 40%.
• You must have a tuberculosis (TB) screening test done before joining.

Who may not be able to join:

• You have not yet recovered from side effects caused by a previous cancer treatment.
• You have an active autoimmune disease (where your immune system attacks your own body) that has needed treatment with medications in the past 2 years — note that simple hormone replacement therapies do not count as this type of treatment.
• You have had a serious allergic reaction to medicines similar to those used in this trial.
• You have had lung inflammation (not caused by infection or COVID) that needed steroid treatment, or you currently have lung inflammation.
• You currently have signs or symptoms of a bowel blockage.
• You have a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• You have a history of a hole forming in your digestive tract (bowel perforation) or painful diverticular disease.
• You have had an infection or abscess inside your abdomen within the past 3 months.
• Your surgeon believes that internal scarring in your abdomen would prevent a catheter from being placed inside for treatment.
• You have a significant irregular heartbeat that has not been stable with medication in the past two weeks.
• You have a known history of a nerve condition affecting your eyes (optic neuritis) or any inflammatory or immune-related condition affecting the brain or nervous system, including a seizure disorder.
• You have a known bleeding disorder, such as hemophilia or von Willebrand's disease.
• You have had a stroke or bleeding in the brain within the past 6 months.
• You have a history of another cancer, unless it was fully treated with the aim of cure, you have had no signs of it for at least 3 years, or it was a certain type of non-serious skin cancer.
• You have an active, uncontrolled infection.
• You have an active hepatitis B or hepatitis C infection.
• You have HIV.
• You have any other condition that the study doctor believes would make participation unsafe for you.
• You have recently received certain other treatments that have not been stopped long enough before joining (confirm with trial site for specific details).
• The study team feels you may not be able to follow all of the study requirements.

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