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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
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.
Primary: To assess the safety of the IP and IV infusions of autologous anti-FSHR T cells with or without prior high-dose cyclophosphamide plus fludarabine. Secondary: -To assess the antitumor efficacy of adoptively transferred anti-FSHR CER T cells -To assess the in vivo persistence of adoptively transferred FSHR T cells Tertiary/Exploratory -To assess whether the infusion of anti-FSHR T cells enhances the expansion of endogenous tumor-targeted T cells -To compare IP and IV routes of administration for tolerability, toxicity, and efficacy -To compare formalin-fixed western blot and FFPE immunohistochemistry (IHC) for FSHR expression
Chemotherapy (NOS); Immunotherapy
FSHR T-Cells (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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