Roswell Park Launches Exclusive Phase 1 Clinical Trial of ‘Armored’ CAR T-Cell Therapy for Ovarian Cancer

While T-cell therapies have revolutionized the treatment of blood cancers, leading to long-term remission or even cure for many patients, solid tumors pose a greater challenge, largely because immune cells struggle to penetrate and survive within the tumor microenvironment. But a new “armored” CAR T-cell therapy equipped for a three-pronged attack is designed to overcome that obstacle in ovarian cancer patients whose disease has relapsed or is refractory to platinum-based chemotherapy, the standard first-line treatment. Roswell Park Comprehensive Cancer Center is currently recruiting for a phase 1 clinical trial of the new therapy (NCT07489287), called GB-5267, which was co-developed by Roswell Park and the therapeutics company Generate:Biomedicines.

Patients’ T cells will be collected and genetically engineered in Roswell Park’s GMP Engineering & Cell Manufacturing Facility. GB-5267 is designed to work in three ways:

• It will target tumors that express the antigen MUC16, which is over-expressed by more than 80% of ovarian tumors.
• It will activate T cells and help them persist.
• It will enhance the proliferation and recruitment of endogenous immune cells.

“Because ovarian cancer spreads through the peritoneal cavity, this CAR T-cell therapy will be delivered in two ways — intravenously and into the peritoneal cavity,” explains Emese Zsiros, MD, PhD, FACOG, Chair of Gynecologic Oncology and Principal Investigator of the trial. “This will concentrate the immune response where it is needed, without the toxicity of high-dose cytotoxic therapy.”

An added advantage is that GB-5267 is the first CAR T-cell therapy that will not require lymphodepletion before the modified T cells are infused in the patient. Lymphodepletion uses chemotherapy to destroy the patient’s endogenous immune cells to avoid rejection of the new T cells and provide more space for them. Eliminating this step means patients will not have to deal with the adverse side effects of chemotherapy.

This novel approach to CAR T-cell therapy provides a hopeful new treatment option for ovarian cancer patients whose disease has recurred after platinum-based chemotherapy. Relapsed/refractory ovarian cancer is very difficult to treat, with few remaining options, and the five-year relative survival rate is only 51.6%.

“CAR T-cell therapy has transformed outcomes in blood cancers,” notes Dr. Zsiros. “With this clinical trial, we are working to bring that progress to ovarian cancer.”

To refer a patient to this study, or to inquire about eligibility, please contact us by emailing physicianrelations@roswellpark.org or calling 716-845-RPMD (7763).