[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608664":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":36,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":10,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":10},{"fullName":5,"class":6},"Shanghai 10th People's Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients with Advanced Bladder Cancer",null,[12],"Biological: Ex Vivo Expanded γδ T Cell Infusion",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"BIOLOGICAL","Ex Vivo Expanded γδ T Cell Infusion","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\u002FDC-CIK, and demonstrates superior ex vivo expansion and tumor-targeting capabilities compared to TIL therap",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"WEI LI, M.D.","CONTACT","86 13817665602","liweitongji@163.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Wei Li","M.D.","100608664","a-clinical-study-on-the-safety-tolerance-and-preliminary-efficacy-of--t-cell-injection-in-the-treatment-of-advanced-bladder-cancer-100608664",false,"NCT07204496","A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer","γδ-T-BLADDER","Inclusion Criteria:\n\nThe subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.\n\nAged 18-75 years, regardless of gender.\n\nDiagnosed with primary bladder cancer confirmed by histopathology or clinical diagnostic criteria, clinically assessed as unresectable, and having failed at least two prior lines of standard therapy.\n\nAdequate organ function:\n\n1. Hematologic system (no transfusion or hematopoietic growth factor therapy within 14 days prior to enrollment):\n\n   Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n\n   Platelets (PLT) ≥60×10⁹\u002FL\n\n   Hemoglobin (Hb) ≥90 g\u002FL\n2. Liver function:\n\n   Total bilirubin (TBIL) ≤1.5×ULN\n\n   Alanine aminotransferase (ALT) ≤3×ULN\n\n   Aspartate aminotransferase (AST) ≤3×ULN\n\n   Albumin ≥2.8 g\u002FdL\n3. Coagulation function:\n\n   Activated partial thromboplastin time (APTT) ≤1.5×ULN\n\n   International normalized ratio (INR) or prothrombin time (PT) within normal range\n4. Renal function:\n\n   Serum creatinine ≤1.5×ULN, or\n\n   Creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using Cockcroft-Gault formula; applies only if creatinine \\>1.5×ULN)\n5. Thyroid function:\n\n   Thyroid-stimulating hormone (TSH) ≤1×ULN\n\n   Free triiodothyronine (FT3) ≤1×ULN\n\n   Free thyroxine (FT4) ≤1×ULN\n6. Cardiovascular function:\n\nLeft ventricular ejection fraction (LVEF) ≥50% by echocardiography\n\nAJCC Bladder Cancer Stage III or IV.\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\nAt least one measurable lesion (according to mRECIST criteria).\n\nExpected survival time ≥6 months.\n\nMale subjects with partners of childbearing potential must use reliable and effective contraception from signing the informed consent form until 180 days after the last dose of the study drug. Male subjects with pregnant partners must use condoms and require no additional contraception methods.\n\nExclusion Criteria:\n\nPrior treatments within 28 days before the first dose:\n\n1. 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).\n2. Major surgical procedures or failure to recover from side effects of such surgeries (excluding minor procedures, e.g., appendectomy, tumor biopsy).\n3. Participation in other interventional drug clinical trials (excluding observational studies or survival follow-up).\n\nFailure to recover from prior antitumor therapy-related toxicities (except alopecia) (i.e., toxicity still \\> Grade 1 or not returned to baseline).\n\nConcurrent or history of other malignancies, except:\n\nCurative basal cell or squamous cell skin cancer\n\nCarcinoma in situ of the cervix\n\nPapillary thyroid carcinoma\n\nDuctal carcinoma in situ of the breast\n\nOther malignancies with disease-free survival \\>5 years\n\nUncontrolled diabetes despite optimal supportive care.\n\nPresence of gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome.\n\nHistory or presence of autoimmune diseases (e.g., rheumatoid arthritis).\n\nNeurological diseases, diffuse leptomeningeal disease, or comorbid neurodegenerative disorders.\n\nHistory or planned stem cell or organ transplantation during the study.\n\nAny of the following within 6 months before the first dose:\n\n1. Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant thromboembolic events.\n2. Unstable angina, myocardial infarction, or symptomatic chronic heart failure.\n3. Ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).\n4. Coronary\u002Fperipheral artery bypass grafting.\n5. Current or history of congestive heart failure (NYHA Class II-IV).\n6. Uncontrolled hypertension despite medication (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg).\n\nActive infections, including:\n\n1. Clinically uncontrolled active infections within 7 days before the first dose (e.g., acute pneumonia, unexplained persistent fever).\n2. Hepatitis B (HBsAg-positive and HBV-DNA \\>1000 IU\u002FmL; HBV carriers must receive antiviral therapy per local guidelines and commit to ongoing treatment during the study).\n3. Hepatitis C (HCV antibody-positive).\n4. HIV or Treponema pallidum (TP) infection.\n\nRequirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants.\n\nPregnancy or lactation.\n\nAny uncontrolled concurrent condition (including psychiatric disorders or substance abuse) deemed by the investigator to compromise subject cooperation or trial participation, or any other reason making the subject unsuitable for the study.",true,"ALL","18 Years","75 Years",{"count":41,"type":42},20,"ESTIMATED","OBSERVATIONAL","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.",[46],"Advanced Bladder Cancer","NOT_YET_RECRUITING","2025-09-24",{"date":50,"type":51},"2025-10-02","ACTUAL",{"date":53,"type":42},"2025-09-26",{"date":55,"type":42},"2026-12-31",{"name":5,"class":6}]