NCT05316129

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

A Phase I Clinical Trial of an Infusion of Autologous T Cells Genetically Engineered With a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients With Recurrent Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Follicle Stimulating Hormone Receptor T Cells	Participants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.

Timeline

• Start date: 2022-04-28
• Primary completion: 2026-07-01
• Completion: 2029-05-01
• First posted: 2022-04-07
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study