Qinghui Lianuo's Off-the-Shelf CAR-γδ T Cell Therapy QH104A Achieves 100% Disease Control Rate and Receives FDA IND Approval for Recurrent High-Grade Glioma

High-grade gliomas, as the most aggressive malignant tumors in the central nervous system, have always been a "tough challenge" in the field of oncology treatment. Glioblastoma, which has the highest incidence rate (accounting for approximately 50% of high-grade gliomas), carries a median overall survival of only 14-16 months after diagnosis, with an expected survival of just 6-8 months after recurrence. The five-year survival rate is less than 7%. Traditional therapies struggle to break through efficacy bottlenecks due to challenges such as the blood-brain barrier and high tumor heterogeneity. QH104A cell therapy innovatively integrates the natural anti-tumor properties of γδ T cells with the precise targeting advantages of CAR-T technology. Data from investigator-initiated trials (IIT) already conducted show that it can significantly extend patient survival, offering hope to potentially break the two-decade-long stagnation in breakthrough therapies and bring new light to glioma patients worldwide.

QH104A, relying on Qinghui Lianuo's self-developed fully enclosed semi-automated production process system, has achieved a breakthrough in the scaled preparation of cell-based drugs, significantly reducing the production cost per dose. Meanwhile, its "allogeneic off-the-shelf" design overcomes the limitations of personalized manufacturing, allowing the drug to be stored long-term in liquid nitrogen, forming an "off-the-shelf" drug reserve that drastically shortens patient waiting times and avoids treatment delays. The clinical approval of QH104A represents the regulatory authority's recognition of Qinghui Lianuo’s scalable allogeneic cell drug production process based on γδ T cells. This process can be extended to more candidate products, providing an industrial model for developing more affordable and accessible cell-based drugs.