We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Through real-world clinical data, we aim to scientifically determine whether this novel T-cell therapy can significantly alter the pathological progression of tumors and improve patient outcomes. Ultimately, we seek to benefit a broader patient population by achieving long-term tumor-bearing or tumor-free survival, transforming cancer management into a chronic disease model and improving patients' quality of life.
None
Chemotherapy, radiotherapy, biologic therapy, immunotherapy, targeted therapy, local therapy, or traditional Chinese medicine with明确抗肿瘤适应症 (clear antitumor indications).
Major surgical procedures or failure to recover from side effects of such surgeries (excluding minor procedures, e.g., appendectomy, tumor biopsy).
Participation in other interventional drug clinical trials (excluding observational studies or survival follow-up).
Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant thromboembolic events.
Participants will be selected from adult patients (aged 18-75 years) with histologically confirmed, unresectable advanced bladder cancer (AJCC Stage III or IV) who have failed at least two prior lines of standard therapy. The population will include individuals with adequate organ function (hematologic, hepatic, renal, cardiac, and coagulation parameters per predefined criteria) and an ECOG performance status of 0-1. Key exclusions comprise active autoimmune diseases, uncontrolled infections, concurrent malignancies, organ transplant recipients, and significant cardiovascular/neurological comorbidities. This trial specifically targets a population eligible for investigational cellular immunotherapy, focusing on those with progressive disease despite conventional treatments.
Cohort
Prospective
Ex Vivo Expanded γδ T Cell Infusion
Biological/VaccineThis 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
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
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