NCT05444322招募中早期 1 期
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
He Huang1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年7月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.
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
- •Aged 18 to 75 years.
- •Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
- •Life expectancy greater than 3 months.
- •Cardiac left ventricle ejection fraction ≥50%.
- •Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
排除标准
- •Pregnant or lactating.
- •Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive.
- •Central nervous system (CNS) metastases.
- •Participated in other clinical studies within 4 weeks prior to screening.
- •History of alcoholism, drug abuse or mental illness.
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
研究组 & 干预措施
RD14-01 cell infusion
Experimental
Infused i.v. in a single dose
干预措施: RD14-01 cell infusion (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: Up to 2 years
DLT
Maximum tolerable dose
时间窗: Up to 2 years
MTD
次要结局
未报告次要终点
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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