Qinghui Lianuo Completes First-in-Human Dosing of QH104A, the World’s First Off-the-Shelf B7-H3-Targeted CAR-γδ T Cell Therapy, in Phase I Clinical Trial

QH104A received clinical trial approvals from the U.S. FDA in May and from China's National Medical Products Administration (NMPA) Center for Drug Evaluation in September this year, after which the project rapidly advanced:

In November, the clinical research kick-off meeting was held in Beijing, comprehensively deploying the implementation process; in December, the research team successfully completed the first patient dosing. From approval, initiation to the first dosing, all环节s were closely connected, and the team's excellent clinical execution ability laid a solid foundation for the smooth progress of subsequent research.

The "off-the-shelf" design of QH104A is its core advantage over traditional therapies. Unlike autologous CAR-T therapy, which requires weeks of personalized preparation, this product is derived from healthy donor cells and can be mass-produced in advance and cryopreserved.In clinical use, there is no need to endure a long wait; it can be quickly revived and utilized after quality rechecks. For patients with recurrent malignant brain tumors, who face rapidly progressing conditions and extremely short treatment windows, this means they can receive treatment more promptly, thereby avoiding potential delays caused by the lengthy preparation cycles of traditional methods. This significantly enhances the accessibility and clinical feasibility of the treatment.

This study focuses on recurrent or progressive malignant tumors of the central nervous system, a field that has long faced the severe challenges of poor prognosis and a lack of effective treatment options. Taking glioblastoma, the most common and highly malignant example, patients’ expected survival after recurrence is only 6-8 months, representing a significant unmet clinical need.

QH104A innovatively combines the natural immune characteristics of γδ T cells with the precise targeting capability of CAR technology, and breaks through accessibility bottlenecks with an "off-the-shelf" model, aiming to provide a new treatment option for this patient population.