A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19（Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events and tumor response rate related to study drug
研究概览
简要总结
Objectives:
The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.
Methods:
This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.
详细描述
A total of 20 patients may be enrolled over a period of 1-2 years.
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
- •Age ≥ 18 years old, male or female
- •Karnofsky≥60%
- •At least 2 courses of chemotherapy were performed
- •Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
- •Adequate venous access, isolation, and white blood cell production without other taboos
- •Signed informed consent
- •Patients with fertility are willing to use contraceptive method.
- •At least two months after infusion of T cells
排除标准
- •Need to use glucocorticoid therapy
- •Need immunotherapy
- •Creatinine > 2.5mg/dL; ALT / AST > 5 times of the normal; bilirubin > 3mg/dL
- •Forced expiratory volume at one second (FEV1)<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)<40%
- •congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO<40%
- •human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
- •Had received gene therapy
- •Significant encephalopathy / new focal neurologic impairment
- •Blood culture positive or radiographic evidence of infection
- •Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
- •The history of allergic reactions in cell therapy and cetuximab similar compounds.
研究组 & 干预措施
CD19-specific chimeric antigen receptor
After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.
干预措施: CD19-specific chimeric antigen receptor (Biological)
结局指标
主要结局
Occurrence of adverse events and tumor response rate related to study drug
时间窗: 2 years
次要结局
未报告次要终点