Bioray Biotech Launches Pivotal Phase I/II Registration Clinical Trial of BRL-201, the World’s First Non-Viral PD-1 Targeted Integration Anti-CD19 CAR-T Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

On March 16, 2023, BRL Medicine announced that it is in the research phase.CAR-TThe kick-off meeting for the registration clinical trial of the cell product (BRL-201) was held at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, marking the official launch of this CAR-T cell clinical trial.

Group Photo of Conference Attendees

The press release mentioned Dr. Zhengbiao Zheng, CEO of BRL Medicine, Dr. Yang Gao, Chief Strategy Officer, Dr. Wei Li, Vice President of Medical and Clinical, and other core members.ManagementLayer leaders, including Director Qiu Lugui, Deputy Directors Liu Wei, Zou Dehui, and Xu Yan from the Hematology Hospital of the Chinese Academy of Medical Sciences, as well as Tian Zhenglong, Chief Operating Officer of Easymedic, attended the meeting.

BRL-201 is a CAR-T product targeting CD19 developed by BRL Medicine using the Quikin CART® platform, indicated for relapsed/refractory B-cell non-Hodgkin's lymphoma.Lymphoma(R/R B-NHL). Notably, this is the world's first CD19-targeted, non-viral PD1 site-specific integrated CAR-T product. It can achieve gene-site-specific integration of CAR-T cells in a single step without using viral vectors, offering advantages such as low cost, short preparation time, simple process, and high safety and efficacy. Traditional CAR-T production primarily relies on viral vectors, which present several significant issues: complex production processes, high costs, long preparation cycles, and potential tumorigenic risks. In comparison, BRL Medicine’s BRL-201 effectively addresses the major challenges posed by viral vectors, demonstrating substantial advantages and potential. Site-specific integration ensures that each CAR sequence is precisely inserted into a specific site in the genome, avoiding the risk of tumorigenesis caused by random insertion, thus maximizing the safety and efficacy of the CAR-T product. With just one step in preparation, it simultaneously achieves sustained CAR expression and regulation of endogenous genes in T cells, significantly reducing the overall preparation time for CAR-T products. Additionally, the non-viral manufacturing process offers potential cost advantages, benefiting more patients. Preclinical and clinical data were published in Nature on August 31, 2022.

This clinical trial is a multi-center Phase I/II registrational clinical trial, with co-leading PI Professor Qiu Lugui from the Hematology Hospital of the Chinese Academy of Medical Sciences. Other leading participating units include the First Affiliated Hospital of Zhejiang University School of Medicine and Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.