NCT07204496尚未招募不适用
A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer
Shanghai 10th People's Hospital0 个研究点目标入组 20 人开始时间: 2025年9月26日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.
- •Aged 18-75 years, regardless of gender.
- •Diagnosed 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.
- •Adequate organ function:
- •Hematologic system (no transfusion or hematopoietic growth factor therapy within 14 days prior to enrollment):
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- •Platelets (PLT) ≥60×10⁹/L
- •Hemoglobin (Hb) ≥90 g/L
- •Liver function:
- •Total bilirubin (TBIL) ≤1.5×ULN
- •Alanine aminotransferase (ALT) ≤3×ULN
- •Aspartate aminotransferase (AST) ≤3×ULN
- •Albumin ≥2.8 g/dL
- •Coagulation function:
- •Activated partial thromboplastin time (APTT) ≤1.5×ULN
- •International normalized ratio (INR) or prothrombin time (PT) within normal range
- •Renal function:
- •Serum creatinine ≤1.5×ULN, or
- •Creatinine clearance (Ccr) ≥50 mL/min (calculated using Cockcroft-Gault formula; applies only if creatinine >1.5×ULN)
- •Thyroid function:
- •Thyroid-stimulating hormone (TSH) ≤1×ULN
- •Free triiodothyronine (FT3) ≤1×ULN
- •Free thyroxine (FT4) ≤1×ULN
- •Cardiovascular function:
- •Left ventricular ejection fraction (LVEF) ≥50% by echocardiography
- •AJCC Bladder Cancer Stage III or IV.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •At least one measurable lesion (according to mRECIST criteria).
- •Expected survival time ≥6 months.
- •Male 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.
排除标准
- •Prior treatments within 28 days before the first dose:
- •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).
- •Failure to recover from prior antitumor therapy-related toxicities (except alopecia) (i.e., toxicity still > Grade 1 or not returned to baseline).
- •Concurrent or history of other malignancies, except:
- •Curative basal cell or squamous cell skin cancer
- •Carcinoma in situ of the cervix
- •Papillary thyroid carcinoma
- •Ductal carcinoma in situ of the breast
- •Other malignancies with disease-free survival >5 years
- •Uncontrolled diabetes despite optimal supportive care.
- •Presence of gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome.
- •History or presence of autoimmune diseases (e.g., rheumatoid arthritis).
- •Neurological diseases, diffuse leptomeningeal disease, or comorbid neurodegenerative disorders.
- •History or planned stem cell or organ transplantation during the study.
- •Any of the following within 6 months before the first dose:
- •Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant thromboembolic events.
- •Unstable angina, myocardial infarction, or symptomatic chronic heart failure.
- •Ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- •Coronary/peripheral artery bypass grafting.
- •Current or history of congestive heart failure (NYHA Class II-IV).
- •Uncontrolled hypertension despite medication (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg).
- •Active infections, including:
- •Clinically uncontrolled active infections within 7 days before the first dose (e.g., acute pneumonia, unexplained persistent fever).
- •Hepatitis B (HBsAg-positive and HBV-DNA >1000 IU/mL; HBV carriers must receive antiviral therapy per local guidelines and commit to ongoing treatment during the study).
- •Hepatitis C (HCV antibody-positive).
- •HIV or Treponema pallidum (TP) infection.
- •Requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants.
- •Pregnancy or lactation.
- •Any 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.
研究组 & 干预措施
Patients with Advanced Bladder Cancer
干预措施: Ex Vivo Expanded γδ T Cell Infusion (Biological)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment to the end of treatment at 30 days
次要结局
未报告次要终点
研究者
Wei Li
M.D.
Shanghai 10th People's Hospital
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