The US Food and Drug Administration (FDA) has approved a Phase II clinical trial for Biosyngen’s BRG01, an EBV-specific CAR-T cell therapy.

This marks the first cell therapy to enter Phase lI trials in both the US and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma.

The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China had previously granted approval for the pivotal Phase II clinical trial of BRG01.

Professor Zhang Li, Director of the Phase I Ward at the Sun Yat-Sen University Cancer Center, and principal investigator for the BRG01 clinical trial, commented: “BRG01 has the potential to be a first-in-class T-cell therapy for EBV-positive tumours, and we are confident in its ability to deliver meaningful clinical benefits to patients with this difficult-to-treat malignancy. “

Patient enrolment for the Phase I clinical trial in China and the US began in late January this year, with all participants having completed the BRG01 infusion.

The Phase I study has successfully concluded dose-limited toxicity (DLT) observation and efficacy evaluation in nine patients with advanced nasopharyngeal carcinoma who had at least one prior immune checkpoint inhibitor treatment, including PD-1 antibodies.

Preliminary data indicates that BRG01 demonstrates exceptional safety and preliminary efficacy. All patients are late-stage cancer patients failing standard treatment including checkpoint inhibitors. BRG01 is so far well tolerated and expanded in patient with no dose-limiting toxicity.

More efficient disease control and tumour shrinkage effects were observed with dose escalation. 75% patients in the high dose group showed necrosis and metabolic reduction of tumour lesions as determined by PET-CT.

As one of the most common head and neck tumours, nasopharyngeal carcinoma is closely related to EBV infection. According to WHO, an estimated number of 133,000 new cases of nasopharyngeal carcinoma worldwide was reported in 2020.

Diana Spencer, Senior Digital Content Editor, DDW