Engineered immune cells take aim at Hard-to-Treat ovarian cancer
NCT ID NCT05316129
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This early-stage study tests a new treatment for people with ovarian cancer that has come back. The therapy uses a patient's own immune cells, which are modified in a lab to recognize and attack a protein (FSHR) found on cancer cells. The main goal is to check the safety of these cells and find the best dose, with or without chemotherapy before the infusion. Ten adults with recurrent ovarian, fallopian tube, or peritoneal cancer will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18 years or older and able to provide informed consent. * Pathologically confirmed diagnosis of invasive (Grades 1-3) epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma (EOC), which are serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated. Borderline serous ovarian tumors (BOT, also known as serous low-malignant potential tumors) are included, as are mixed invasive/borderline cancers. Patients may also have sex cord-stromal tumors (SCSTs) to include adult-type granulosa cell tumors (GCTs) and Sertoli Leydig cell tumors (SLCTs), or SCSTs with mixed elements that include at least one of these types. * Have measurable disease or detectable (non-measurable) disease. * Consent to have tumor obtained for correlative study testing. * Patients must have had 1 prior platinum-based chemotherapeutic regimen for the management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least 2 prior chemotherapy regimens. * Patients should be considered platinum- refractory (progression while on a prior platinum chemotherapy) or resistant (persistence or recurrence within 6 months after a prior platinum chemotherapy) and be deemed unlikely to have significant benefit from any standard therapies by the treating investigator. * Patients with a known germline or somatic BRCA pathogenic mutation should receive a PARP inhibitor if treatment would be consistent with the current FDA approval for use of PARPi at time of screening, unless they have a documented history of intolerance or inability to swallow oral medications. * For Granulosa Cell Tumors (GCTs), at least one hormonal regimen (i.e., letrozole) should be included in prior therapies. * For Borderline Ovarian Tumors, documentation of the consideration of a MEK inhibitor (e.g., trametinib) should be included. * For high-grade serous (Grades 2,3), eligibility and consideration of Folate Receptor-alpha antibody drug conjugate (e.g., mirvetuxumab) should be considered and documented for patients who meet all FDA label criteria. * Patients are allowed to receive, but are not required to receive, up to 6 additional prior (for a total of 8 prior treatments) chemotherapy treatment regimens (including platinum-based chemotherapy). Prior maintenance therapy with an agent when there has not been progression will not be a separate treatment regimen. Prior hormonal therapy is allowed, and when used alone, even as a therapeutic agent, it does not count toward this prior regimen requirement. Hormonal therapy must be discontinued at least 1 week before T-cell infusion. Continuation of hormone replacement therapy is permitted. * Patients are allowed to receive, but are not required to receive, biologic/targeted therapy alone or as part of their treatment regimens. When used as treatment after progression, these treatments will count as a separate therapy. * Eastern Cooperative Oncology Group (ECOG) status of 2 or better (or Karnofsky Performance Status score of ≥60%). * Life expectancy of at least 3 months. * Adequate bone marrow, renal, and hepatic function (liver function and renal tests, grade 1 or lower): * No anticancer therapy (chemotherapy, biologic therapy, or immunotherapy) in the 3 weeks before the T-cell infusion (and all hematologic effects have resolved). * No prior immunotherapy with checkpoint blockade (e.g., PD1 inhibitor, PDL1 inhibitor, or CTL4- antagonist or similar agent) in the 3 months before the T-cell infusion (and all clinically significant related side effects must be resolved). * Patient agrees to undergo placement of surgically placed peritoneal port and central line catheter. (may be temporary or subcutaneous). * Although it is anticipated that patients who are eligible for this study will not have childbearing potential, any patient the treating doctor or investigator deems to have childbearing potential must agree to an acceptable means of contraception from the time of screening to at least 6 months after T-cell infusion. Exclusion Criteria: * Known active hepatitis B infection, known history of hepatitis C or HIV infection. * Clinical or radiographic evidence of bowel obstruction or need for parenteral hydration and/or nutrition. * Known or suspected extensive abdominal adhesions that would preclude port placement or infusion. * Any of the following cardiac conditions: Clinically significant heart disease (New York Heart Association class 3 or 4) or symptomatic congestive heart failure. Myocardial infarction \<6 months before enrollment. History of clinically significant ventricular arrhythmia or unexplained syncope that is not believed to be vasovagal in nature or due to dehydration. History of severe non-ischemic cardiomyopathy with ejection fraction \<20%. Findings on baseline ECG or ECHO that, in the opinion of the patient's treating physician or investigator, would require medical intervention before anticancer therapy * Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen). Such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis. * Known or suspected leptomeningeal disease and patients with metastases to the brain stem, midbrain, pons, or medulla. * Known or suspected untreated brain metastases. Patients with radiographically stable, asymptomatic previously irradiated lesions are eligible provided patient is \>4 weeks beyond completion of cranial irradiation and \>3 weeks off of corticosteroid therapy at the time of study intervention. * Prior history of clinically significant seizure disorder (e.g., not including childhood febrile seizures). * Any concurrent active malignancies, defined as malignancies requiring any therapy other than expectant observation, because adverse events (AEs) resulting from these malignancies or their treatment may confound our assessment of the safety of adoptive T-cell therapy for ovarian cancer. * Prior radiotherapy to any portion of the abdominal cavity or pelvis. * Current lactation or pregnancy * Any of the following within 28 days of first date of study treatment: Serious uncontrolled medical illness or disorder that in the opinion of the treating physician would make the patient ineligible for the study. Active uncontrolled infection (with the exception of uncomplicated urinary tract infection). Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess. Abdominal surgery (for reasons other than IP port placement). * Any other issue which, in the opinion of the treating physician or principal investigator, would make the patient ineligible for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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- Can a pill shrink Hard-to-Treat ovarian tumors?