NCT02839954Unknown1 期
Study Evaluating the Efficacy and Safety of Chimeric Antigen Receptor-Modified pNK Cells in MUC1 Positive Advanced Refractory or Relapsed Solid Tumor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with MUC1+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
- •Eligible diseases: MUC1+ malignant glioma of brain, colorectal carcinoma, gastric carcinoma, hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma.
- •Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
- •MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
- •Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than
- •Presence of measurable disease by RECIST.
- •Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR-pNK cells.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
- •Ability to give informed consent.
排除标准
- •Patients with symptomatic central nervous system (CNS) involvement.
- •Pregnant or nursing women may not participate.
- •Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- •The existence of unstable or active ulcers or gastrointestinal bleeding.
- •Patients with a history of organ transplantation or are waiting for organ transplantation.
- •Patients need anticoagulant therapy (such as warfarin or heparin).
- •Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
结局指标
主要结局
Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells
时间窗: 2 years
Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
次要结局
- Phase II: Objective Response Rate(2 years)
研究者
研究点 (1)
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