NCT05454241已完成2 期
Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年9月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Overall Response Rate(ORR)
研究概览
简要总结
This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.
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
- •Diagnosed CD7 positive relapsed/refractory hematological malignancies.
- •Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- •The estimated survival time is more than 3 months;
- •Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- •The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
排除标准
- •Patients with history of epilepsy or other central nervous system diseases;
- •Patients with prolonged QT or severe heart disease;
- •Pregnant or lactating women
- •Patients with uncontrolled active infection.
- •Positive for any of the following etiological tests: HIV, HBV, HCV
- •Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
研究组 & 干预措施
anti-CD7 UCAR-T cells
Experimental
干预措施: Anti-CD7 CAR-T (Drug)
结局指标
主要结局
Overall Response Rate(ORR)
时间窗: 1 Year
Number of patients who achieved response after treatment of CD7 CAR-T cell.
次要结局
- Duration of overall response (DOR)(1 Year)
- Overall survival(OS)(1 Year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIODSchimke Immuno-osseous DysplasiaNCT06769191Zhejiang University20
Unknown
1 期
Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies MalignanciesT-Cell Lymphocytic LeukemiaT-Cell Chronic Lymphocytic LeukemiaT Cell Non-Hodgkin LymphomaNCT04823091Wuhan Union Hospital, China24
Unknown
2 期
CD7 CAR T-cell for R/R CD7+ T Cell LymphomaRefractory and Relapsed T Cell LymphomaNCT05059912The First Affiliated Hospital of Soochow University20
招募中
1 期
CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic LeukaemiaLymphoblastic Leukemia, Acute, ChildhoodLymphoblastic LeukemiaLymphoblastic Leukemia, Acute AdultLymphoblastic Leukemia in ChildrenCARCAR T-Cell-Related Encephalopathy SyndromeRefractory LeukemiaNCT05043571National University Hospital, Singapore20
进行中（未招募）
不适用
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaSenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaNCT04916860Hebei Senlang Biotechnology Inc., Ltd.100