BUFFALO, N.Y. and SOMERVILLE, Mass. — October 1, 2026
Roswell Park Comprehensive Cancer Center and Generate Biomedicines, Inc. announced that the first patient has been dosed in a first-in-human Phase 1 clinical trial of GB-5267, an investigational autologous IL-18-armored CAR T-cell therapy for ovarian cancer. The treatment is designed to address challenges that have limited CAR T-cell activity in solid tumors. GB-5267 targets MUC16, a tumor-associated antigen overexpressed in more than 80% of ovarian tumors, and is being evaluated in patients whose disease has returned or is resistant to platinum-based chemotherapy. The trial is designed to evaluate the safety and tolerability of the investigational therapy.
GB-5267 Uses AI-Designed CAR T-Cell Engineering
Generate Biomedicines engineered GB-5267 using its AI-enabled platform to optimize three functions considered important for CAR T-cell activity in solid tumors: potency, proliferation and persistence. The therapy incorporates IL-18, a cytokine intended to help T cells function within the immunosuppressive tumor microenvironment. Patient T cells are collected, genetically modified and expanded at Roswell Park’s GMP Engineering & Cell Manufacturing Facility before being administered back to the patient. The treatment targets MUC16-expressing tumor cells while seeking to maintain T-cell activity within the tumor environment.
Trial Evaluates Dual Delivery Without Lymphodepletion
The Phase 1 study is evaluating GB-5267 using both intravenous and intraperitoneal administration, reflecting the spread of ovarian cancer through the peritoneal cavity. The approach is intended to deliver CAR T cells systemically while also concentrating treatment within the peritoneal cavity. Unlike many CAR T-cell treatment approaches, the trial does not require lymphodepletion, a chemotherapy-based process used to reduce existing immune cells before CAR T-cell administration. The companies said avoiding lymphodepletion is intended to eliminate the associated chemotherapy side effects. The trial is being led by Emese Zsiros, MD, PhD, FACOG, Chair of Gynecologic Oncology at Roswell Park.
Advertisement
Generate and Roswell Park Advance Solid Tumor Cell Therapy
GB-5267 is being evaluated in Phase 1 clinical development as Generate Biomedicines and Roswell Park seek to extend CAR T-cell therapy into solid tumors. The trial is registered as NCT07489287 and is recruiting patients with recurrent or platinum-resistant ovarian cancer. Generate’s function-first design approach uses computational engineering and biological experimentation to develop CAR architectures based on T-cell behavior rather than binding affinity alone. The companies are evaluating whether the optimized potency, proliferation and persistence characteristics of GB-5267 can translate into clinical activity in the challenging solid-tumor setting. The first patient dose marks the beginning of clinical evaluation for the AI-engineered CAR T-cell candidate and provides the first opportunity to assess its safety and tolerability in patients with ovarian cancer.
Source:Roswell Park,, press release
