Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion
研究概览
简要总结
This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
- •Representative tumor specimens as specified by the protocol
- •Adequate hematologic and end organ function
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than or equal to (>/=) 12 weeks
- •Measurable disease, as defined by RECIST v1.1
排除标准
- •Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •Leptomeningeal disease
- •Malignancies other than UBC within 5 years prior to Cycle 1, Day 1
- •Pregnant and lactating women
- •Significant cardiovascular disease
- •Severe infections within 4 weeks prior to infusion
- •Major surgical procedure other than for diagnosis within 4 weeks
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- •History of autoimmune disease
- •Prior allogeneic stem cell or solid organ transplant
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
研究组 & 干预措施
4SCAR-FRa
4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.
干预措施: 4SCAR-FRa (Genetic)
4SCAR-PSMA
4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.
干预措施: 4SCAR-PSMA (Genetic)
结局指标
主要结局
Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion
时间窗: 3 months
to evaluate the level of adverse events with CTCAE 4
Overall Survival rate after receiving 4SCART infusion
时间窗: 1 year
to determine the efficacy of 4SCAR T cells
次要结局
- The expansion and persistence of 4SCAR T cells(1 year)
- Immune responses after infusions(3 months)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute