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Successful Launch of Phase I Clinical Trial for BC008-1A Injection in Treating Malignant Glioma

Release time:2025-02-28
Recently, the kickoff meeting and investigator training session for the "Phase I Clinical Trial to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Treating Subjects with Recurrent CNS WHO Grade 4 Glioma" was successfully held at Beijing Tiantan Hospital, Capital Medical University. The trial is sponsored by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. and organized by Beijing Leadingpharm ·Shenlanhai (Zhengzhou).

Attendees included Academician Jiang Tao, Principal Investigator (PI) Professor Zhang Wei and his research team from Beijing Tiantan Hospital, Capital Medical University; Ms. Li Shuya, Director of the Clinical Trial Center; several authoritative experts from the hospital; Mr. Yang Chun, General Manager of the sponsor Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.; and Mr. Zhu Haobin, Deputy General Manager of Leadingpharm CXO · Deep Blue Ocean Bio-Pharmaceuticaland Chief Medical Officer of the Clinical Pharmacology Research Center. The meeting was chaired by Mr. Yang Huijun, Project Manager of Beijing Leadingpharm · Shenlanhai (Zhengzhou).
 

 
BC008-1A Injection is a new bio-macromolecular bispecific antibody anti-tumor drug developed by the sponsor Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. Specifically, BC008-1A Injection (Recombinant Anti-PD-1/TIGIT Humanized Bispecific Antibody Injection) is a bispecific antibody targeting human programmed death receptor 1 (PD-1) and TIGIT. This immunotherapeutic drug aims to promote T cell reactivation, enhance the anti-tumor activity of NK cells, and improve anti-tumor effects by simultaneously blocking the PD-1/PD-L1 and TIGIT/CD155 pathways. As China's first clinical trial of PD-1/TIGIT bispecific antibody for recurrent CNS WHO Grade 4 glioblastoma (rGBM), the project intends to evaluate the safety and preliminary efficacy of BC008-1A Injection in adult subjects with recurrent CNS WHO Grade 4 glioma. It is expected to provide a more effective treatment option for patients with recurrent glioma and represents a cutting-edge breakthrough in China's solid tumor treatment field.

During the meeting, under the leadership of PI Professor Zhang Wei, participating experts conducted in-depth discussions on key issues such as project protocol interpretation and project operation management. They unanimously agreed that the clinical trial of BC008-1A Injection holds significant scientific value and social significance, and put forward valuable guiding suggestions for the implementation of the project protocol.

The successful holding of this meeting has laid a solid foundation for the smooth progress of the research project. With the official launch of the trial, all parties involved will strictly follow the requirements of the trial protocol to ensure the scientific and efficient execution of the clinical trial. It is anticipated that BC008-1A Injection will demonstrate favorable efficacy and safety in future clinical trials, bringing new hope to patients with recurrent malignant glioma.

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