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Recruiting Phase 1 NCT05316129

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

Trial Parameters

Condition Ovarian Cancer
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 10
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-04-28
Completion 2026-07
Interventions
Follicle Stimulating Hormone Receptor T Cells

Brief 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.

Eligibility 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 chemo

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