A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer

This study involves the use of γδ T cell infusion, a non-genetically modified adoptive cellular immunotherapy. The intervention utilizes autologous γδ T cells isolated from peripheral blood and expanded ex vivo using specific activators such as zoledronate and cytokines, without genetic engineering. Its mechanism of action relies on the inherent MHC-unrestricted tumor recognition capability of γδ T cells, activating both the NKG2D-NKG2DL axis and BTN3A1-CD277 pathway for dual antitumor activity. The manufacturing process follows GMP-compliant closed-system conditions, with final product release criteria requiring ≥80% purity for CD3+γδ TCR+ cells, along with sterility testing, endotoxin detection, and cytotoxicity assays. This approach fundamentally differs from genetically modified αβ T cell-based therapies like CAR-T or TCR-T, as well as non-specific immunotherapies such as CIK/DC-CIK, and demonstrates superior ex vivo expansion and tumor-targeting capabilities compared to TIL therap