Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up Women only

Infusion of modified T cells to target ovarian cancer

Official title: 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

Run by H. Lee Moffitt Cancer Center and Research Institute · NCT05316129 · Data updated 2026-11-12

This study is testing a new treatment using modified immune cells to see if they can safely help people with recurring ovarian cancer.

More Ovarian Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment10 (estimated)
SponsorH. Lee Moffitt Cancer Center and Research Institute
Academic / other
Drugs / interventionsmirvetuxumab, trametinib, chemotherapy, immunotherapy
Locations1 site (Tampa, Florida)
StatusRecruiting
StartedApril 28, 2022
Main results expectedOctober 2026
Study endsMay 2029
Registry record updatedSeptember 17, 2026
Trial IDNCT05316129 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a confirmed diagnosis of invasive epithelial ovarian cancer or related conditions who have previously undergone platinum-based chemotherapy.

Probably not a fit

Patients with non-invasive ovarian tumors or those who have not received prior chemotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety of autologous T cells that have been genetically modified to express a chimeric endocrine receptor targeting the follicle-stimulating hormone receptor in patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. Participants may receive these engineered T cells with or without conditioning chemotherapy. The study aims to assess the feasibility and safety of this innovative treatment approach in a Phase 1 setting.

Why it matters

Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients with recurrent ovarian cancer.

How similar studies have gone: While this approach is novel, similar studies using engineered T cells have shown promise in other cancer types, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.