NCT05845502终止不适用
Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
Shantou University Medical College1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年7月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The incidence rates and severity of AEs
研究概览
简要总结
This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ003 in the treatment of advanced hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With advanced hepatocellular carcinoma (HCC) confirmed by histopathology;
- •With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression;
- •Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy;
- •Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ;
- •With at least one stable evaluable target lesion according to RECIST 1.1 criteria, which was defined as: non-nodal lesion longest diameter ≥10 mm, or nodal lesion short diameter ≥15 mm;
- •Age 18-80, male or female;
- •Karnofsky Performance Status (KPS)≥80;
- •Stable vital signs and expected survival at least 12 weeks.
- •If HBsAg or HBcAb is positive, HBV-DNA < 200 IU/ml and to receive anti-HBV therapy ((Entecavir or tenofovirdisoproxil) for at least 14 days prior to the start of study treatment;
- •Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L;
- •Blood biochemistry: Alb≥30g/L, Lipase and Amylase ≤1.5 ULN, Serum creatinine ≤1.5 ULN, creatinine clearance ≥40mL/min, ALT≤5 ULN, AST≤5 ULN, Total Serum bilirubin ≤2.5 ULN, prothrombin time ≤6s;
- •Be able to understand and sign an informed consent form
排除标准
- •With uncontrolled active infections;
- •No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation.
- •With previous history of encephalopathy.
- •With active acute or chronic virus, germ infection;
- •Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases;
- •Other serious medical conditions that may limit participation in the trial (such as poorly controlled diabetes (treated Glycated hemoglobin HbA1c > 7%) , severe heart failure (left ventricular ejection fraction (LVEF) < 45%) , myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, Interstitial lung disease, pulmonary function test FEV1 < 60% predicted, gastric ulcer, history of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency) ;
- •Ascites more than 5cm;
- •The proportion of liver replaced by tumor≥70%, or with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver;
- •Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation);
- •Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy.
- •Long-term systemic steroid therapy or patients with autoimmune diseases;
- •With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study;
- •Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation.
- •Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement;
- •Pregnant or lactating women;
- •Inappropriate to participate in this clinical trial by investigator's judgement.
研究组 & 干预措施
SZ003 CAR-NK
Experimental
干预措施: SZ003 CAR-NK (Biological)
结局指标
主要结局
The incidence rates and severity of AEs
时间窗: through study completion, an average of 1 year
To evaluate the safety of SZ003 CAR-NK Cells
次要结局
- overall survival (OS)(up to 2 years)
- disease control rate (DCR) and objective response rate (ORR)(up to 2 years)
- progression-free survival (PFS)(up to 2 years)
- duration of response (DOR)(up to 2 years)
研究者
Yao KaiTao
Deputy Director
Shantou University Medical College
研究点 (1)
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