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New treatment option for Ovarian Cancer
Official title Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT05316129
What this study is testing
What is Follicle Stimulating Hormone Receptor T Cells?
Follicle Stimulating Hormone Receptor T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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)...
- 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...
You likely can't join if
- 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...
- Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen). Such conditions include but are not limited to systemic...
- Known or suspected leptomeningeal disease and patients with metastases to the brain stem, midbrain, pons, or medulla.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- Any other issue which, in the opinion of the treating physician or principal investigator, would make the patient ineligible for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.