Emese Zsiros, MD, PhD
First-in-human Folate Receptor alpha-targeted BiTE-secreting T cells ovarian cancer clinical trial
2026 Collaborative Research Development Grant
Health Research, Inc., and Roswell Park Cancer Institute
Project Summary
This proposal will evaluate the safety and feasibility of treating relapsed ovarian cancer (OC) using a novel adoptive T cell therapy (BiTE-secreting T cells). This therapy represents a bench-to-bedside approach to improve clinical outcomes for OC patients who develop treatment refractory cancer. This Phase 1 trial will be complemented by mechanistic studies designed to assess therapy-driven changes associated with clinical response. Findings from this first-in-human study will support submission of new collaborative MPI grants to enroll additional OC patients in an expansion trial using BiTE-secreting T cells, with the goal of identifying an effective therapeutic option for OC patients.
Bio
Dr. Emese Zsiros, MD, PhD, is a physician scientist, an Associate Professor, and the Shashi Lele MD Endowed Chair in Gynecologic Oncology at Roswell Park Comprehensive Cancer Center in Buffalo, NY, as well as the Co-Leader of the Tumor Immunology and Immunotherapy Cancer Center Support Grant program. Dr. Zsiros earned a combined MD/PhD at the University of Debrecen (Hungary)/Universidad de Complutense (Spain). She completed her residency at Northwestern University and pursued her Gynecologic Oncology fellowship at the University of Pennsylvania under the mentorship of Dr. George Coukos. She has been named a Buffalo Spree Top Doctor in gynecologic oncology since 2019, received the Buffalo Business First Excellence in Healthcare Award in 2023, and recently received the inaugural Breaking Barriers Award for Visionary Leadership from Roswell Park in 2025. She has made impactful differences in patients’ lives, such as reducing hospital-wide opioid consumption across surgical services, as well as influencing NCCN guidelines (with clinical trial NCT02853318) by expanding treatment options (a triple combination of the immune checkpoint inhibitor pembrolizumab, the anti-VEGF agent bevacizumab, and oral metronomic cyclophosphamide) for recurrent, platinum-resistant OC patients, as the only immunotherapy regimen currently listed in the guideline for this patient population.Dr. Zsiros’ research has focused on immunotherapy approaches and improving efficacy in gynecologic oncology by exploring combination therapies and modulation of the tumor microenvironment, primarily in women with OC. She has been a PI or Co-Investigator on over 145 clinical trials and currently has NIH and DOD funding to lead two investigator-initiator ovarian cancer clinical trials (NCT04919629 and NCT05231122) on APL-2, a C3 complement inhibitor, and immune checkpoint blockade + bevacizumab +/- a CD40 agonist, respectively. Additional research interests include developing therapeutic approaches with her collaborators that enhance immunotherapy strategies, including immune checkpoint blockade, adoptive cell transfer, BiTEs, and CAR-T therapies, to improve survival and quality of life for patients. She also recently received Roswell Park Alliance Foundation funding as PI with her co-I, Dr. Bob McGray, to evaluate the clinical impact of folate receptor alpha (FRα)-targeted BiTE-secreting T cells that Dr. McGray has developed. This grant will focus on completing activities for an IND filing. This current Ovarian Cancer Research Alliance Collaborative Research Development Award with Drs. Zsiros, McGray, and their collaborator, Dr. Mark Long, an expert in the use of multi-omics to identify correlates of responses following immunotherapy, will conduct a FRα-targeted BiTE-secreting T cells clinical trial in OC patients. This proposal will support the first-in-human clinical evaluation of a novel adoptive T cell therapy, representing an opportunity to improve clinical outcomes for OC patients who recur following initial treatment, while also generating important correlative data to identify OC patients most likely to benefit from FR-B T cell therapy.