A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation

Hebei Senlang Biotechnology Inc., Ltd.1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2020年4月1日最近更新: 2020年11月13日

适应症

干预措施

试验速览

阶段: 早期 1 期
发起方
入组人数: 50
试验地点: 1
主要终点: Number of Participants with Severe/Adverse Events as a Measure of Safety

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

详细描述

This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

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 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
•ECOG score≤2;
•To be aged 1 to 65 years;
•More than a month lifetime from the consent signing date.

排除标准

•Serious cardiac insufficiency, left ventricular ejection fraction<50%;
•Has a history of severe pulmonary function damaging;
•Merging other progressing malignant tumor;
•Merging uncontrolled infection;
•Merging the metabolic diseases (except diabetes);
•Merging severe autoimmune diseases or immunodeficiency disease;
•Patients with active hepatitis B or hepatitis C;
•Patients with HIV infection;
•Has a history of serious allergies on Biological products (including antibiotics);
•Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
•Pregnancy or lactation women;
•Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.