Phase 1 Ovarian 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:

• People who have been diagnosed with ovarian cancer (confirmed by lab testing of tissue or cells), including types such as serous, endometrioid, clear cell, mucinous, mixed, or undifferentiated. Pure sarcoma, stromal, or germ-cell tumours are not included, but mixed tumours that are mostly high-grade carcinoma (such as carcinosarcoma) may be eligible.
• People who have at least one tumour that can be measured on a scan or physical examination, meeting specific size requirements depending on how it is measured (confirm with trial site for exact measurements).
• People who have stored tissue samples available from a previous biopsy, or who are willing to have a new biopsy taken. A specific protein marker (B7-H3) does not need to be present.
• People aged 18 or older.
• People who have received at least one prior platinum-based chemotherapy treatment for ovarian cancer, and whose cancer either progressed during that treatment or returned within six months of completing it, after all standard curative treatments have been tried.
• People who have waited at least three weeks (or five half-lives of the drug, whichever is shorter) since their last cancer treatment — or at least three months since their last immune checkpoint therapy.
• People whose side effects from previous treatments have mostly resolved to a mild or baseline level (with some exceptions such as hair loss or mild nerve symptoms).
• People with a general health and activity level rated as reasonably functional (ECOG score of 2 or better, or Karnofsky score of 60% or above — confirm with trial site).
• People whose treating doctor estimates they have a life expectancy of at least three months.
• People whose blood counts, kidney, liver, heart, and lung function meet the specific levels required by the trial (confirm with trial site for exact values).
• Women of childbearing potential who have a negative pregnancy test before joining, and who are willing to use effective contraception from enrolment until at least four months after the last treatment dose, or until the trial's CAR T cells are no longer detectable in the blood.
• People who are able to understand the study information and are willing to sign a consent form approved by an ethics review board.

Who may not be able to join:

• People who have an active or uncontrolled infection requiring treatment within one week before screening (simple urinary tract infections or uncomplicated throat infections that are responding to treatment may be acceptable).
• People who need to take corticosteroid tablets or injections at doses higher than a low maintenance level (more than 5 mg per day of prednisone or equivalent). Topical, inhaled, or eye steroid medications are allowed.
• People who have an abdominal fistula (abnormal connection between organs), a hole in the gastrointestinal tract, or an abscess inside the abdomen.
• People who have had another type of cancer within the past two years, unless it was fully treated with no known active disease for at least two years, or was a skin cancer (non-melanoma) that has been fully treated with no signs of return.
• People who have certain heart conditions, including: moderate to severe heart failure (NYHA stage III or IV); a heart attack or heart bypass surgery within the past six months; significant irregular heartbeat or unexplained fainting (unless caused by dehydration or a simple reflex response); or a history of severe non-ischemic heart muscle disease.
• People with active or poorly controlled autoimmune diseases, such as Crohn's disease, rheumatoid arthritis, lupus, or systemic vasculitis.
• People with an ongoing HIV, hepatitis B, or hepatitis C infection. A past history of hepatitis B or C may be acceptable if the virus is undetectable on specialised blood testing.
• People with untreated or active cancer spread to the brain. People with previously treated, stable, and symptom-free brain lesions may be eligible if at least four weeks have passed since brain radiation and at least three weeks have passed since stopping corticosteroids.
• People with known allergies or sensitivities to any of the medications used in this study, including steroids, tocilizumab, DMSO, cyclophosphamide, or fludarabine.
• People with a known history of clinically significant seizure disorder (childhood febrile seizures are generally not included in this).
• People who, in the opinion of the treating doctor or principal investigator, have any other condition that would make participation unsuitable.

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