A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- efficacy of CAR-T therapy
研究概览
简要总结
The purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies
详细描述
Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in hematological malignancies. However, response rates and associated immune-related adverse effects widely vary among patients. And no biomarkers have been identified to predict the efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical experiments and clinical studies have shown that gut microbiota was associated with the efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic malignancies, gut microbiota was associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy is unclear. Therefore, in this study, we aim to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-65 years.
- •Hematologic malignancies intended for CAR-T therapy.
- •Expected survival time ≥ 3 months (according to investigator's judgement).
- •Left ventricular ejection fractions ≥ 55% by echocardiography.
- •ALT / AST <3 times of normal amounts.
- •Creatinine<2.0mg/dl.
- •PT and APPT <2 times of normal amounts.
- •Karnofsky performance status ≥
- •The ECOG score ≤2 points.
排除标准
- •Pregnant (or lactating) women;
- •Uncontrolled active infection；
- •Active infection of hepatitis B virus or hepatitis C virus；
- •Human immunodeficiency virus (HIV) positive；
- •Patients with a history of myocardial infarction or severe arrhythmia within six months or those with class III or IV cardiac function according to the New York classification；
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
结局指标
主要结局
efficacy of CAR-T therapy
时间窗: six months
CR，PR and NR
toxicity of CAR-T therapy
时间窗: six months
Adverse events are evaluated with CTCAE V5.0
gut microbiota
时间窗: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
diversity and composition of the gut microbiota
次要结局
未报告次要终点