A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adverse events of each patient.
研究概览
简要总结
The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
详细描述
Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
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
- 4 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
- •Life expectancy>3 months.
- •Gender unlimited, age from 4 years to 75 years.
- •Disease progresses but reserves reaction to recent treatments.
- •Patients who have failed at least one line of a standard treatment.
- •No serious mental disorder.
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •No other tumors.
- •Patients volunteer to participate in the research.
排除标准
- •HIV affected.
- •Patients are allergic to cytokines.
- •Central nervous system leukemia within 28 days.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •Pregnancy and nursing females.
- •Other situations we think improper for the research.
研究组 & 干预措施
Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
干预措施: Chimeric Antigen Receptor Modified T cells Targeting CD19 (Biological)
Chronic Lymphcytic Leukemia
Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
干预措施: Chimeric Antigen Receptor Modified T cells Targeting CD19 (Biological)
Non-Hodgkin Lymphoma
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
干预措施: Chimeric Antigen Receptor Modified T cells Targeting CD19 (Biological)
结局指标
主要结局
Adverse events of each patient.
时间窗: 3 years
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
次要结局
- Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.(4 weeks)
- Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells(12 weeks)
- Survival time of Anti-CD19 CAR T cells in vivo.(3 years)
研究者
Shiqi Li
Researcher of Biotherpy Center
Southwest Hospital, China