Cancer Type: Gynecological Tumor
Study Type: Treatment
Phase: Phase I
Principal Investigator: Wenham, Robert
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
Cell Therapy; Chemotherapy (NOS)
FSHR T-Cells (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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