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OncoMatch/Clinical Trials/NCT05316129

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

Is NCT05316129 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Follicle Stimulating Hormone Receptor T Cells for ovarian cancer.

Phase 1RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05316129Data as of May 2026

Treatment: Follicle Stimulating Hormone Receptor T CellsThe 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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Allowed: BRCA1 pathogenic mutation

Allowed: BRCA2 pathogenic mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 8 prior lines
Min 2 prior lines

Must have received: platinum-based chemotherapy

Patients must have had 1 prior platinum-based chemotherapeutic regimen for the management of ovarian, primary peritoneal, or fallopian tube carcinoma

Must have received: cytotoxic chemotherapy

at least 2 prior chemotherapy regimens

Cannot have received: radiation therapy

Prior radiotherapy to any portion of the abdominal cavity or pelvis

Cannot have received: checkpoint inhibitor

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).

Lab requirements

Blood counts

adequate bone marrow function (grade 1 or lower)

Kidney function

renal tests, grade 1 or lower

Liver function

liver function tests, grade 1 or lower

Cardiac function

No clinically significant heart disease (NYHA class 3 or 4), symptomatic CHF, MI <6 months, clinically significant ventricular arrhythmia, severe non-ischemic cardiomyopathy with EF <20%, or findings on ECG/ECHO requiring intervention

Adequate bone marrow, renal, and hepatic function (liver function and renal tests, grade 1 or lower): 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida

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