Ovarian CancerPhase 1NCT05316129
Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer
A Phase 1 study testing Follicle Stimulating Hormone Receptor T Cells in people with Ovarian Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Follicle Stimulating Hormone Receptor T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Ashley K O'Neil, 813-745-5240, Ashley.ONeil@moffitt.org
Kimberly Sprenger, 813-745-0330, Kimberly.Sprenger@moffitt.org
About this study
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
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.
- Conditions
- Ovarian Cancer
- Being tested
- Follicle Stimulating Hormone Receptor T Cells
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle Stimulating Hormone Receptor T CellsDrug
Participants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal treatment- Dose Level 1 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intravenous treatment - Dose Level 1 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5 by Intravenous (IV). Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intraperitoneal treatment- Dose Level 2 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intravenous treatment - Dose Level 2 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5 by Intravenous (IV). Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intraperitoneal treatment- Dose Level 3 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intravenous treatment - Dose Level 3 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6 by Intravenous (IV). Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intraperitoneal treatment- Dose Level 4 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intravenous treatment - Dose Level 4 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6 by Intravenous (IV). Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intraperitoneal treatment- Dose Level 5 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
| Intravenous treatment - Dose Level 5 | Experimental | Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7 by Intravenous (IV). Receives: Drug: Follicle Stimulating Hormone Receptor T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of FSHCER T Cells
Participants will receive escalating doses of FSHCER T Cells to determine the Maximum Tolerated Dose (MTD). MTD is defined as the the highest dose of t cells that does not cause unacceptable side effects.
Measured: Day 1
Secondary outcomes (3)
Duration of Response
The duration of response is measured from the time measurement criteria are met for immune complete response or immune partial response (whichever is first recorded) until the first date that progressive disease (immune related progressive disease -irPD) is objectively documented (taking as reference for PD the smallest measurements recorded [nadir] since the treatment started).
Measured: Up to 15 years
Duration of Stable Disease
Stable Disease is measured from the start of the treatment until the criteria for confirmed progressive disease are met.
Measured: Up to 15 years
Overall Survival
Overall survival defined as the time from initial date of treatment to date of death.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start28 Apr 2022
- Primary completionOct 2026 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Anixa Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert M Wenham, MD, MS, FACOG, FACS, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316129
- Sponsor's protocol ID
- MCC-21113
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05316129
- Acronym / sponsor ID
- MCC-21113
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Anixa Biosciences, Inc.
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal treatment- Dose Level 1 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. |
| Intravenous treatment - Dose Level 1 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5 by Intravenous (IV). |
| Intraperitoneal treatment- Dose Level 2 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. |
| Intravenous treatment - Dose Level 2 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5 by Intravenous (IV). |
| Intraperitoneal treatment- Dose Level 3 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. |
| Intravenous treatment - Dose Level 3 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6 by Intravenous (IV). |
| Intraperitoneal treatment- Dose Level 4 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. |
| Intravenous treatment - Dose Level 4 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6 by Intravenous (IV). |
| Intraperitoneal treatment- Dose Level 5 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity. |
| Intravenous treatment - Dose Level 5 | Experimental | Drug: Follicle Stimulating Hormone Receptor T CellsParticipants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7 by Intravenous (IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follicle Stimulating Hormone Receptor T CellsParticipants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER. | Drug | Intraperitoneal treatment- Dose Level 1, Intraperitoneal treatment- Dose Level 2, Intraperitoneal treatment- Dose Level 3, Intraperitoneal treatment- Dose Level 4, Intraperitoneal treatment- Dose Level 5, Intravenous treatment - Dose Level 1, Intravenous treatment - Dose Level 2, Intravenous treatment - Dose Level 3, Intravenous treatment - Dose Level 4, Intravenous treatment - Dose Level 5 |
Primary outcome
Maximum Tolerated Dose of FSHCER T Cells
Time frame: Day 1
Participants will receive escalating doses of FSHCER T Cells to determine the Maximum Tolerated Dose (MTD). MTD is defined as the the highest dose of t cells that does not cause unacceptable side effects.
3 secondary outcomes
Duration of Response
Time frame: Up to 15 years
Duration of Stable Disease
Time frame: Up to 15 years
Overall Survival
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert M Wenham, MD, MS, FACOG, FACS principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follicle Stimulating Hormone Receptor T Cells in people with Ovarian Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley K O'Neil (813-745-5240, Ashley.ONeil@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of FSHCER T Cells (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.