QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors

This is an early-phase clinical study conducted to initially evaluate the safety, tolerability, and preliminary biological activity of QH101, an allogeneic TCR-enhanced Vδ2 T cell therapy, in patients with advanced solid tumors who have exhausted standard treatment options. The study adopts an open-label, non-randomized design to fully observe the in vivo performance of QH101, which is engineered to express BTN protein-specific binding elements without co-stimulatory signal domains or the CD3ζ domain. Prior to QH101 infusion, eligible patients will receive a standardized lymphodepletion regimen to create a favorable immune microenvironment for the homing, expansion, and persistence of infused Vδ2 T cells. QH101 will be administered via intravenous infusion, with a gradual dose-escalation strategy implemented to explore the safe dose range. Throughout the study, patients will undergo close clinical monitoring to track any adverse events associated with the therapy, with a particular focus on immune-related toxicities and infusion-related reactions, given the unique design of QH101 that avoids T cell exhaustion from overactivation. In addition to safety monitoring, the study will collect serial peripheral blood samples at predefined time points to assess the in vivo persistence, activation status, and tissue homing potential of QH101. Correlative studies will be conducted to explore the interaction between QH101 and the tumor microenvironment, especially the binding efficiency of BTN protein-specific binding elements to tumor-expressed BTN2A1/BTN3A1, as well as the relationship between the in vivo dynamics of QH101 and preliminary antitumor activity. The primary goal of this early clinical research is to confirm the safety profile of QH101, determine the feasible dose range for subsequent studies, and obtain preliminary evidence of its biological activity, including in vivo persistence and tumor-targeting capability. The findings from this study will lay a solid foundation for the further clinical development of QH101, providing critical insights into its potential as a novel cellular therapy for advanced solid tumors.