Qinghui Lianuo Launches Phase I Clinical Trial of QH104A: World’s First Allogeneic B7-H3-Targeted CAR-γδ T Cell Therapy for Recurrent or Progressive CNS Malignancies
Unicet Biotech
Developer of γδ T Cell Therapeutics
On November 22, Beijing Qinghui Lienuo Biotechnology Co., Ltd. (hereinafter referred to as "Qinghui Lienuo") announced thatQinghui LianuoThe kick-off meeting for the "A Single-Arm, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of QH104A Cell Injection in Patients with Recurrent or Progressive Central Nervous System Malignant Tumors," led by Beijing Tiantan Hospital, Capital Medical University (referred to as "Beijing Tiantan Hospital"), was successfully held in Beijing recently. QH104A Cell Injection is the world's first universal CAR-γδ T cell candidate drug targeting B7-H3, independently developed by Qinghui Lianuo. The study is led by Professor Wenbin Li of Beijing Tiantan Hospital as the Principal Investigator (PI).
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At the launch meeting, the research team focused on core aspects such as the implementation of the research protocol, refinement of patient enrollment criteria, standardization of medication procedures, key points of safety monitoring, and data management quality. They conducted systematic and in-depth discussions along with hands-on training, laying a solid foundation for the standardized implementation of the clinical trial and comprehensive quality control throughout the process.
Professor Li Wenbin pointed out: "Malignant tumors of the central nervous system have high mortality, high recurrence rates, and extremely poor prognosis, with a long-standing lack of clinical treatment options. In recent years, CAR-T therapy has gradually shown breakthrough potential in the field of solid tumors, and QH104A, as the world's first universal CAR targeting B7-H3—γδ TCellular products, with unique mechanisms of action and therapeutic potential. We look forward to scientifically and precisely evaluating their safety and efficacy through this clinical study, bringing new hope for treatment to patients in need."
QH104A Cell Injection Combines Three Core Technological Innovations: First, the CAR structure precisely targets the B7-H3 antigen, which is highly expressed in various central nervous system tumors, enabling targeted and accurate elimination of tumor cells. Second, the introduction of engineered signaling components significantly enhances the persistence and anti-tumor functionality of the cell therapy in vivo. Third, its off-the-shelf design overcomes the time and cost limitations of individualized cell production, offering potential for scalable clinical application. In investigator-initiated clinical studies, QH104A has already demonstrated promising safety and anti-tumor activity. The product received clinical trial approval from both the U.S. FDA and China's National Medical Products Administration Center for Drug Evaluation in 2025, and also obtained FDA Orphan Drug Designation.
Statistics show that the incidence of malignant tumors in the central nervous system continues to rise. Taking glioblastoma as an example, the five-year survival rate for patients is less than 7%, and there is a lack of effective treatments after recurrence, making the unmet clinical needs extremely urgent. The advancement of clinical research on QH104A cell injection may offer a new treatment pathway for these patients while also injecting momentum into China’s leadership in the innovative development of the global cell therapy field.
In the future, Qinghui Lianuo will closely collaborate with Beijing Tiantan Hospital and all partners, deeply synergizing to advance the clinical research process of QH104A cell injection with high standards and strict requirements, accelerating product development and striving to benefit a wide range of patients as soon as possible.
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