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.
Treatment: Follicle Stimulating Hormone Receptor T Cells — 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.
Check if I qualifyExtracted 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
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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