Gene Key Life's GKL-006 Injection Launches Third Trial Site for Pivotal Clinical Study at The First Hospital of Shanxi Medical University

Dec 31, 2024 10:13 CST Updated 10:13

Gene Key

Developer of Immune Cell Product Technologies and Provider of Clinical Application Services

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Recently, the registration clinical trial of "GKL-006 Injection," an iNKT cell therapy product independently developed by Beijing Gene Key Life Technology Co., Ltd., has officially started at the First Hospital of Shanxi Medical University. As the third trial center for this clinical trial, it marks a brand-new phase in the clinical trial of GKL-006 Injection. Participants included Wang Yusheng, Director of the Oncology and Gastroenterology Department; Feng Duiping, Director of the Oncology and Vascular Intervention Department; quality control officers from the Clinical Drug Research Institution; key representatives from the trial sponsor; and clinical research teams from both the Oncology and Gastroenterology Department and the Oncology and Vascular Intervention Department.

The First Hospital of Shanxi Medical University, as a comprehensive hospital integrating medical treatment, teaching, and research, possesses strong scientific research capabilities and extensive clinical experience. This collaboration with Gene Key Life Technology will fully leverage its professional advantages in the field of oncology to provide robust support for the registration clinical trial of GKL-006 injection.

Director Wang Yusheng and Director Feng Duiping, as the Principal Investigators (PIs) of the clinical trial, will lead the research team to strictly implement the clinical trial protocol, ensuring the scientific rigor, standardization, and safety of the trial. Both directors possess extensive clinical experience and a strong research background; their participation will inject new momentum into the clinical trial of GKL-006 injection. Director Wang Yusheng has required the clinical research team to adhere to the code of conduct, implement procedures with caution, objectively document findings, strictly comply with GCP guidelines, and resolutely complete the study with high quality according to the trial implementation plan and processes.

The collaboration between the First Hospital of Shanxi Medical University and Beijing Gene Key Life Technology Co., Ltd. will jointly promote the development of the tumor immunotherapy field, bringing hope and benefits to more patients. We look forward to the complete success of the GKL-006 injection clinical trial, providing new treatment options for cancer patients.

Beijing Gene Key Life Technology Co., Ltd

Beijing Gene Key Life Technology Co., Ltd. was established in 2015 and is located at No. 3 Tian Gui Street, Daxing Biomedical Industry Base, Zhongguancun Science Park, Daxing District, Beijing. It is the world's first leading company to develop a series of iNKT cell pipeline products; it has a biomedical and immunology basic research team, an iNKT cell basic research platform, a clinical research platform, and a large-scale cell culture system for expansion. A National High-tech Enterprise, Zhongguancun High-tech Enterprise, Beijing "Specialized, Refined, Distinctive, and Innovative" enterprise, science and technology SME, intellectual property pilot unit, leading cell industry enterprise in the Zhongguancun Biomedical Base, Vice Chairman Unit of the Daxing District Science and Technology Association of Beijing, Vice Chairman Unit of the Beijing Specialized, Refined, Distinctive, and Innovative Enterprises Chamber of Commerce, and a 2024 Credit Leading Enterprise. It has obtained multiple national and international invention patents and owns fully independent intellectual property rights for its iNKT cell super-expansion platform and unique subpopulation distribution, among other breakthrough technologies.

Major Breakthrough:

(1) Completed the world's first safety and efficacy validation of iNKT cell therapy for primary liver cancer;

(2) GKL-006 Injection for the treatment of unresectable primary hepatocellular carcinoma received the clinical trial approval (Clinical Trial Notification No.: 2023LP02333) from the National Medical Products Administration (NMPA);

(3) GKL-006 Injection for the prevention of high-risk recurrence in patients with primary hepatocellular carcinoma after radical resection has received the clinical trial approval (Clinical Trial Notification No.: 2024LP01859) from the National Medical Products Administration (NMPA).

(4) GKL-006 Injection for the treatment of advanced pancreatic cancer has received the registration clinical trial approval from the National Medical Products Administration (NMPA) (Clinical Trial Notification No.: 2024LP02731).

China has initially completed the core technology breakthrough and industrial upgrade in the field of iNKT cell therapy, achieving a "leading" position in this area and contributing to the accelerated development of new quality productive forces.

Source of the article:Gene Key