Phase 1 GB-5267 IL-18–armored anti-MUC16 CAR T cell therapy in platinum-resistant ovarian cancer.

This first-in-human, open-label Phase 1 dose-escalation study tests GB-5267, an autologous CAR T-cell product engineered to recognize MUC16 (a surface antigen commonly expressed in epithelial ovarian cancers) and “armored” with IL-18 to enhance local immune activation and persistence in solid tumors. The trial’s primary purpose is to define safety/tolerability and a recommended dose, with secondary evaluation of early antitumor activity and cellular kinetics/biologic effects. Participants have platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer (O/F/P), a setting where current care is sequential systemic therapy such as non-platinum chemotherapy (often with bevacizumab when appropriate), PARP inhibitors for selected biomarker-defined patients, and later-line options including antibody-drug conjugates in some jurisdictions—yet responses are frequently short-lived. The protocol includes an IV CAR T approach and a planned cohort exploring combined IV + intraperitoneal (IP) delivery to better address peritoneal-dominant disease, a practical anatomic challenge for cellular therapies in ovarian cancer. The study is sponsored by Roswell Park Comprehensive Cancer Center, with GB-5267 developed in partnership with Generate Biomedicines.