NCT04538599已完成1 期
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
He Huang1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 3 to 70 years.
- •Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
- •Life expectancy greater than 12 weeks.
- •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 core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
- •Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- •Participated in other clinical studies within 2 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
RD13-01 cell infusion
Experimental
干预措施: RD13-01 cell infusion (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 4 weeks after infusion
次要结局
未报告次要终点
研究者
He Huang
PhD
Zhejiang University
研究点 (1)
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