Phase I Clinical Study on the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The incidence of dose limiting toxicity (DLT )
研究概览
简要总结
The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
详细描述
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in clinical studies;
- •ECOG score 0-1 points;
- •Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
- •At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions>1.5cm, and the longest diameter of extranodal lesions>1.0cm.
排除标准
- •Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
- •Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
- •Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), and severe arrhythmia.
结局指标
主要结局
The incidence of dose limiting toxicity (DLT )
时间窗: 28 days after infusion
The incidence, severity, and types of dose limiting toxicity
The incidence of TEAEs
时间窗: 28 days after infusion
The incidence, severity, and types of adverse events that occur during treatment
次要结局
- OS(24 months after infusion)
- ORR(24 months after infusion)
- PFS(24 months after infusion)