NCT02944162Unknown1 期
Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
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10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
- Adverse events attributed to the administration of the anti-CD33 CAR-NK cells
研究概览
简要总结
The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
详细描述
PRIMARY OBJECTIVES:
Determine the safety and feasibility of the chimeric antigen receptor NK92 cells transduced with the anti-CD33 vector (referred to as anti-CD33 CAR-NK cells).
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-leukemia response due to anti-CD33 CAR-NK cell infusions.
II. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by anti-CD33 CAR-NK in vitro.
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
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (>12 weeks to < 2 year survival) with currently available therapies will be enrolled.
- •CD33+ acute myeloid leukemia CR (complete remission) can not be achieved after at least 2 prior combination chemotherapy regimens.
- •AML in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.
- •Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
- •Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
- •Residual disease after primary therapy and not eligible for autologous SCT.
- •All of those patients must also meet the following criteria:
- •Expected survival > 12 weeks. Creatinine < 2.5 mg/dl ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal Bilirubin < 2.0 mg/dl Any relapse after prior SCT will make patient eligible regardless of other prior therapy.
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- •Ability to give informed consent.
排除标准
- •Pregnant or nursing women may not participate.
- •Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
- •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.
- •History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
- •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 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
Adverse events attributed to the administration of the anti-CD33 CAR-NK cells
时间窗: One year
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
次要结局
- Objective Response Rate(Up to one year)
研究者
研究点 (1)
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