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 aged 18 or older who are able to give informed consent to participate.
• People who have been diagnosed with a specific type of ovarian, primary peritoneal, or fallopian tube cancer that has been confirmed by a pathology test, including certain grades and types such as serous, endometrioid, clear cell, mucinous, mixed, or undifferentiated; borderline serous ovarian tumors; or certain sex cord-stromal tumors including granulosa cell tumors and Sertoli Leydig cell tumors.
• People whose cancer can be measured or detected on scans or tests.
• People who agree to have a tumor sample taken for research testing as part of the trial.
• People who have already received at least one platinum-based chemotherapy and at least two chemotherapy regimens in total for their cancer.
• People whose cancer either progressed during platinum-based chemotherapy (platinum-refractory) or came back or continued growing within 6 months of finishing platinum-based chemotherapy (platinum-resistant), and whose treating doctor considers it unlikely that standard treatments would provide meaningful benefit.
• People with a known BRCA gene mutation who have already received a PARP inhibitor treatment (where this was consistent with approved use at the time of screening), unless they had a documented reason for being unable to take it.
• For people with granulosa cell tumors: prior treatment must have included at least one hormonal therapy, such as letrozole.
• For people with borderline ovarian tumors: the treating doctor must have documented consideration of a MEK inhibitor, such as trametinib.
• For people with high-grade serous cancer (grades 2 or 3): the treating doctor must have documented consideration of a folate receptor-alpha antibody drug conjugate, such as mirvetuxumab, where all relevant approved criteria were met.
• People who have received up to 8 prior treatment regimens in total (note: prior hormonal therapy used alone and maintenance therapy without progression do not count toward this total, though hormonal therapy must be stopped at least one week before the T-cell infusion; hormone replacement therapy may continue).
• People who have received prior biologic or targeted therapy (these count as a separate regimen when used after disease progression).
• People with a general health status rated as ECOG 2 or better, or a Karnofsky Performance Score of 60% or higher (confirm with trial site if unsure what this means for a specific situation).
• People with a life expectancy of at least 3 months.
• People with adequate bone marrow, kidney, and liver function, with relevant test results at grade 1 or lower.
• People who have not received any anti-cancer therapy (chemotherapy, biologic, or immunotherapy) in the 3 weeks before the T-cell infusion, and whose blood counts have returned to normal.
• People who have not received checkpoint immunotherapy (such as PD-1, PD-L1, or CTLA-4 inhibitors) in the 3 months before the T-cell infusion, and in whom any related side effects have resolved.
• People who agree to have a surgically placed peritoneal port and a central line catheter inserted as part of the treatment.
• People who the treating doctor considers to have the potential to become pregnant must agree to use an acceptable form of contraception from the time of screening until at least 6 months after the T-cell infusion.

Who may not be able to join:

• People with a known active hepatitis B infection, a known history of hepatitis C, or a known history of HIV infection.
• People with evidence of a bowel obstruction, or who require intravenous fluids or nutrition.
• People with known or suspected extensive internal abdominal scarring (adhesions) that would prevent the placement of the peritoneal port or delivery of treatment.
• People with certain significant heart conditions, including: serious heart disease (New York Heart Association class 3 or 4) or symptomatic heart failure; a heart attack within the past 6 months; a history of clinically significant irregular heart rhythms or unexplained fainting not due to dehydration or a common benign cause; a history of severe non-ischemic heart muscle disease with poor heart function (ejection fraction below 20%); or heart test findings that the treating doctor feels would need to be treated before starting anti-cancer therapy.
• People with an active autoimmune disease (excluding well-controlled autoimmune thyroid disease), such as lupus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, or temporal arteritis.
• People with known or suspected cancer spread to the membranes surrounding the brain and spinal cord, or to certain parts of the brainstem.
• People with known or suspected untreated cancer spread to the brain (note: people with previously treated, stable, symptom-free brain metastases may be eligible if it has been more than 4 weeks since completing brain radiation and more than 3 weeks since stopping steroid treatment — confirm with trial site).
• People with a prior history of a clinically significant seizure disorder (childhood febrile seizures are not included in this).
• People who currently have another active cancer that requires treatment beyond watchful observation, as side effects from that cancer or its treatment could affect the safety assessment for this trial.
• People who have previously received radiation therapy to any part of the abdomen or pelvis.
• People who are currently pregnant or breastfeeding.
• People who, within 28 days before the first treatment, have had: a serious uncontrolled medical condition that the treating doctor considers would make participation inappropriate; an active uncontrolled infection (other than an uncomplicated urinary tract infection); an abdominal fistula, gastrointestinal perforation, or abscess in the abdomen; or abdominal surgery for reasons other than placement of the peritoneal port.
• People whom the treating doctor or principal investigator considers ineligible for any other reason.

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