Recently, Bio-Raid (hereinafter referred to as "Bio-Raid") announced that the companyCell therapy drug independently developed -Autologous T-cell Injection Modified by Chimeric Antigen Receptor Targeting CD30 (hereinafter referred to as "BRD-01")Phase II Registration Clinical Trial Kick-off MeetingSuccessfully convened at the Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. This clinical research project is jointly led by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology as the two leading units. As of the time of writing, eight research centers have completed project approval, and the leading units have obtained ethical approval.
This meeting was held in a combination of online and offline formats. Professor Zhang Yicheng, as the PI of the leading group unit, delivered the opening speech at this launch meeting. He stated: "I am very honored to serve as the PI for the BRD-01 Phase II clinical trial project. The results of the Phase I clinical trial conducted at our center have demonstrated the excellent safety and efficacy of BRD-01. We hope that the Phase II clinical trial of BRD-01 will continue to bring clinical benefits and treatment hope to patients, and we wish the BRD-01 Phase II clinical trial project a successful completion." Hematological experts including Professor Huang Wei, Professor Zhou Xiaoxi, Professor Wang Di, Professor Gao Lili, as well as representatives from Bio-Raid Biotechnology Co., Ltd., such as founder Professor Zhang Tongcun, Dr. Sun Qihong, and Dr. Zhang Shangkun, along with representatives from CROs and SMOs, totaling more than 30 people, attended this launch meeting both online and offline.
BRD-01-II is a Phase II clinical study evaluating the efficacy and safety of autologous T-cell injections genetically modified with chimeric antigen receptors targeting CD30 in patients with CD30-positive relapsed/refractory classical Hodgkin lymphoma. During the kick-off meeting, the project team introduced the clinical research protocol of BRD-01-II, including the study background, design, trial procedures, inclusion/exclusion criteria, drug management, risk control, as well as the protection of participants' rights and safety. The clinical research team and the project operations team conducted in-depth discussions and exchanges regarding the implementation of the study, hoping to accelerate the translation and clinical application of this product through the joint efforts of all parties. Finally, Professor Zhang Tongcun, founder of Bio-Raid Biotechnology Co., Ltd., expressed heartfelt gratitude to the clinical experts and project team involved in the BRD-01 clinical trial, and stated that Bio-Raid will remain true to its original mission and continue to focus on developing high-quality products to bring hope to more patients.
The launch of this initiation meeting marks the official start of the BRD-01 Phase II clinical trial.
BRD-01, independently developed by Bio-Raid (Wuhan) Biotechnology Co., Ltd., is a CAR-T cell therapy drug targeting CD30+ hematological tumors in patients diagnosed with relapsed/refractory conditions. It is also the first CAR-T cell therapy product in China to gain regulatory approval for clinical trials with CD30 as the target, and it has the potential to become the world’s first new drug in this targeted CAR-T category.
The Department of Hematology at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, was established in 1959. With a long history, it is one of the earliest hematology specialties in China. It is currently a national key discipline, a doctoral program in internal medicine (hematology), a medical postdoctoral research station, and the National Emergency Treatment Center for Radiation Sickness. The department boasts strong medical expertise, leading equipment, and is currently leading several major national scientific and technological development fund projects. It is among the first group in China to conduct clinical research on CAR-T cell therapy and enjoys a prestigious reputation in the field of CAR-T cell therapy both domestically and internationally.
