NEW YORK – Biosyngen this week said the US Food and Drug Administration cleared it to begin a Phase II trial of its Epstein-Barr virus (EBV)-specific CAR T-cell therapy, BRG01, as a treatment for relapsed or metastatic nasopharyngeal carcinoma.
The company has completed a Phase I trial of the product in which nine patients with advanced EBV-positive nasopharyngeal carcinoma showed preliminary signs of efficacy. The product was safe and well tolerated with no dose-limiting toxicities. All patients in the trial had failed standard treatment, including checkpoint inhibitors. Among the group receiving the highest dose, 75 percent showed tumor necrosis and reduction of lesions.
China's National Medical Products Administration has also cleared the company to begin Phase II studies of BRG01.
The Singapore-based firm is additionally conducting clinical trials of several tumor infiltrating lymphocyte therapies in the US and China, including BST02 in liver cancer.