Pamela Garzone, PhD
Anixa BioSciences
"FSHR is a tissue specific antigen expressed in >55% of high-grade epithelial ovarian cancers (OVCAs) with negligible FSHR expression in non-ovarian tissues. OVCA xenografts treated with FSHCER T (FSH-Chimeric Endocrine Receptor T-Cell (CER T)) cells resulted in cytotoxic activity against patient-derived FSHR+ OVCA. We hypothesize targeting FSHR in women with FSHR+ OVCA will result in improved response rates and acceptable toxicity.
The primary objective of the phase 1 dose-escalation study in high-grade epithelial OVCA is to assess the safety of IP and intravenous (IV) infusions of engineered FSHCER T cells. Secondary objectives include antitumor efficacy and expansion and persistence of FSHCER T cells.
Three to 6 patients are infused with escalating doses of FSHCER+ T-cells to establish the maximum tolerated dose (MTD). Seven dose levels are planned with the 5th level and beyond receiving lymphodepletion. Tumor sample FSHR gene expression is assessed with a clinically validated 204 gene panel (nCounter, Bruker, Inc). Blood samples are evaluated for cytokines, T-cell receptor repertoire and fluorescence-activated cell sorting (FACS).
Thirteen patients were enrolled in the first four cohorts with one replacement in cohort 4 for non-DLT discontinuation. All enrolled patients cleared the 28-day DLT window and all cell dosages were well tolerated. One patient received a second dose of 3e5 FSHCER+ cells/kg after 20 months of stable disease. Translational studies are underway.
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The primary objective of the phase 1 dose-escalation study in high-grade epithelial OVCA is to assess the safety of IP and intravenous (IV) infusions of engineered FSHCER T cells. Secondary objectives include antitumor efficacy and expansion and persistence of FSHCER T cells.
Three to 6 patients are infused with escalating doses of FSHCER+ T-cells to establish the maximum tolerated dose (MTD). Seven dose levels are planned with the 5th level and beyond receiving lymphodepletion. Tumor sample FSHR gene expression is assessed with a clinically validated 204 gene panel (nCounter, Bruker, Inc). Blood samples are evaluated for cytokines, T-cell receptor repertoire and fluorescence-activated cell sorting (FACS).
Thirteen patients were enrolled in the first four cohorts with one replacement in cohort 4 for non-DLT discontinuation. All enrolled patients cleared the 28-day DLT window and all cell dosages were well tolerated. One patient received a second dose of 3e5 FSHCER+ cells/kg after 20 months of stable disease. Translational studies are underway.
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