Roswell Park Comprehensive Cancer Center is one of only four sites in the U.S. and the only one in New York State offering a phase 1 clinical trial of an investigational cellular therapy strategy for the treatment of recurrent or refractory epithelial ovarian, primary peritoneal or fallopian tube cancer. The study centers on 27T51, a CAR T-cell therapy targeting Mucin-16 (MUC16), also known as CA-125. This antigen is over-expressed in more than 80% of ovarian cancers and is associated with disease progression.
Emese Zsiros, MD, PhD, FACOG, Chair, Department of Gynecologic Oncology at Roswell Park, serves as the site Principal Investigator of the non-randomized, open-label study (NCT06469281). “This trial is designed to evaluate an experimental CAR T-cell therapy targeting MUC16, a well-established ovarian cancer antigen,” explains Dr. Zsiros.
“By combining CAR T-cell therapy with checkpoint blockade and anti-angiogenic therapy, the trial is studying whether the investigational combination can help enhance T-cell persistence, improve immune activation and counteract the immunosuppressive tumor microenvironment in the hope of improving outcomes for patients with advanced disease.”
Study Design
Sponsored by Regeneron Pharmaceuticals, the study comprises two phases: dose escalation and dose expansion.
In the dose-escalation phase, participants will receive 27T51 as a monotherapy, to gauge the highest dose that can be given without unacceptable side effects.
In the dose-expansion phase, patients will be assigned to one of three treatment arms:
Arm A: 27T51 monotherapy
Arm B: 27T51 in combination with an FDA-approved checkpoint inhibitor
Arm C: 27T51 in combination with an FDA-approved checkpoint inhibitor and an FDA-approved anti-angiogenic agent
The median survival for patients with recurrent or refractory ovarian cancer is less than 24 months, highlighting the urgent need for innovative therapies that may improve patient outcomes. “For patients with recurrent or refractory ovarian cancer, treatment options remain limited, with most therapies providing only modest improvements in progression-free survival,” notes Dr. Zsiros. “The current standard of care involves platinum- and taxane-based chemotherapy, followed by targeted agents such as PARP inhibitors or anti-angiogenic agent, but outcomes remain poor.”
Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by regulatory authorities, and which has not received marketing authorization in any country.
BROADCASTMED