Roswell Park Comprehensive Cancer Center and Generate Biomedicines (NASDAQ: GENB) announced that the first patient has been dosed in a phase 1 clinical trial evaluating GB-5267, an investigational CAR T-cell therapy for ovarian cancer.

The trial, identified as NCT07489287, is evaluating the safety and tolerability of GB-5267 in patients whose ovarian cancer has returned after treatment or does not respond to platinum-based chemotherapy. It is led by principal investigator Emese Zsiros, MD, PhD, Chair of Gynecologic Oncology at Roswell Park.

GB-5267 is an autologous CAR T-cell therapy engineered with AI to target MUC16, an antigen expressed in more than 80% of ovarian tumors. The therapy is described as "armored" with IL-18, a cytokine intended to help T cells function within the suppressive microenvironment surrounding solid tumors.

Each patient's T cells will be collected, genetically engineered, and expanded at Roswell Park's cell manufacturing facility before being returned to the patient. The therapy will be administered both intravenously and directly into the peritoneal cavity, the space where ovarian cancer commonly spreads.

Unlike many CAR T-cell approaches, the trial does not require lymphodepletion, a process that uses chemotherapy to reduce a patient's existing immune cells prior to infusion, meaning patients will not be exposed to associated chemotherapy side effects.

Generate states that GB-5267 was designed using a function-first approach, optimizing three properties: potency, proliferation, and persistence. "Dosing the first patient begins the clinical test of whether that function-first approach behaves in patients as intended," said Dinesh de Alwis, PhD, Senior Vice President and Head of Clinical Drug Development at Generate Biomedicines.

The five-year relative survival rate for ovarian cancer is 51.6%, according to the press release. CAR T-cell therapies have previously shown results in blood cancers but have faced challenges in treating solid tumors.