跳至主要内容
临床试验/NCT05619861
NCT05619861招募中不适用

Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor

Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Safety: Incidence and severity of adverse events

研究概览

简要总结

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

详细描述

Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

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
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
  • Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
  • Age 14-70 (including boundary value), both male and female;
  • Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG);
  • The results of treatment related antigens were positive;
  • The expected life span is more than 3 months from the date of signing the informed consent;

排除标准

  • 未提供

结局指标

主要结局

Safety: Incidence and severity of adverse events

时间窗: 24 months post CAR-T cells infusion

The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period

次要结局

未报告次要终点

研究者

发起方
Hebei Senlang Biotechnology Inc., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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