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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer

A Phase I Clinical Trial of an Infusion of Autologous T Cells Genetically Engineered With a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients With Recurrent Ovarian Cancer

Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer (NCT05316129) is a Phase 1 interventional studying Ovarian Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this first in human study is to evaluate the safety of treatment with autologous T cells genetically modified to express a CER (chimeric endocrine receptor) targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Ovarian Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged 18 years or older and able to provide willing to sign a consent form. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Follicle Stimulating Hormone Receptor T Cells

Participants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Moffitt Cancer Center
Tampa, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05316129), the sponsor (H. Lee Moffitt Cancer Center and Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05316129 clinical trial studying?

The purpose of this first in human study is to evaluate the safety of treatment with autologous T cells genetically modified to express a CER (chimeric endocrine receptor) targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05316129?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05316129?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05316129. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05316129. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.