Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer (NCT05316129) | Clinical Trial Compass
RecruitingPhase 1
Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer
United States10 participantsStarted 2022-04-28
Plain-language 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 recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.
Who can participate
Age range18 Years
SexFEMALE
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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 o…
What they're measuring
1
Maximum Tolerated Dose of FSHCER T Cells
Timeframe: Day 1
Trial details
NCT IDNCT05316129
SponsorH. Lee Moffitt Cancer Center and Research Institute