Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer (OVCA).
Background: FSHR is a tissue specific antigen expressed in > 55% of high-grade epithelial OVCAs with negligible FSHR expression in non-ovarian tissues. OVCA xenografts treated with FSHCER T (FSH-Chimeric Endocrine Receptor + T-Cell (CER T)) cells demonstrated cytotoxic activity against patient-derived FSHR+ ovarian carcinomas. We hypothesize targeting FSHR in women with FSHR+ OVCA will result in improved response rates due to engraftment, expansion, and survival of these adoptively transferred FSHCER T-cells and will have acceptable toxicity. Methods: The primary objective of this phase 1 dose-escalation study (NCT05316129) in high-grade epithelial OVCA using T-cells genetically modified to express CER targeting FSHR is to assess the safety of the intraperitoneal (IP) and intravenous (IV) infusions of FSHCER T-cells. Secondary objectives include antitumor efficacy, persistence of transferred FSHR T cells, expansion of endogenous tumor-targeted cells, and comparison of IP and IV administration routes. Patients unable to be treated in the IP arm may be treated in the IV arm in the lowest unfilled cohort for that arm. Cohorts of 3 to 6 patients will be infused with escalating doses of FSHCER T-cells to establish the maximum tolerated dose (MTD) with 6 planned dose levels from 1 x105 to 1 x 107 cells/kg with the 5th level receiving lymphodepleting chemotherapy. Following MTD determination, an expansion phase will be initiated. Nine patients have been enrolled in the first three dose-level cohorts. Eight have cleared the DLT period and one patient is currently being treated. One patient received a second dose of 3 x 105 cells/kg after 20 months apparent stable disease. Cohorts 1 and 2 correlates are being processed. NCT05316129. Moffitt Scientific Review #21113. Advarra Institutional Review Board #00000971.
Disclaimer
This material on this page is ©2025 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Similar Abstracts
Abstract
2024 ASCO Annual Meeting
YF550-C1, an E3 ligase inhibitor of CBL-B, to demonstrate T cell and NK cell activation and anti-tumor activities in syngeneic and PDX tumor model.
First Author: jie YE
Abstract
2024 ASCO Genitourinary Cancers Symposium
Final results of a phase I trial of HERV-E TCR transduced T cells for the treatment of HLA-A*11 patients with metastatic clear cell renal cell carcinoma (mccRCC).
First Author: Rosa Nadal
Abstract
2022 ASCO Genitourinary Cancers Symposium
Attamage-A1: Phase I/II study of autologous CD8+ and CD4+ transgenic t cells expressing high affinity MAGE-A1-specific T-cell receptor (TCR) combined with anti-PD(L)1 in patients with metastatic MAGE-A1 expressing cancer.
First Author: Michael Thomas Schweizer
Abstract
2025 ASCO Gastrointestinal Cancers Symposium
Phase I study of autologous CD8+ and CD4+ transgenic T cells expressing high-affinity KRAS G12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) in patients with metastatic pancreatic, colorectal, and non-small cell lung cancers with KRAS G12V mutations.
First Author: Rachael Safyan
