, /PRNewswire/ -- Biosyngen, a leading biotechnology company focused on the development of innovative cell therapies, recently announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in has approved the initiation of a pivotal Phase ll clinical trial evaluating BRG01, the company's autologous Epstein-Barr virus (EBV) specific chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of patients with recurrent or metastatic EBV-positive nasopharyngeal carcinoma. , representing a significant milestone in the field of cell-based immuno-therapies for solid cancers. "The approval of the Phase ll clinical trial for BRG01 is a testament to the robust preclinical data and strong early clinical results observed with this innovative therapy" said Professor , Director of the Phase l Ward at the Sun Yat-Sen University Cancer Center and Deputy Director of the Lung Cancer Research Institute at Sun Yat-sen University, who is serving as the principal investigator for the BRG01 clinical trial.
"BRG01 has the potential to be a first-in-class T-cell therapy for EBV-positive tumors, and we are confident in its ability to deliver meaningful clinical benefits to patients with this difficult-to-treat malignancy." The Phase l clinical trial of BRG01 in and the U.S.
has completed patient enrollment in January this year. All participants have received BRG01 infusion as part of this registered clinical trial. The Phase l study has successfull.