An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)

Hebei Senlang Biotechnology Inc., Ltd.1 个研究点分布在 1 个国家目标入组 100 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: 100
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 clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

详细描述

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

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

•Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
•Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.
•To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
•There should be at least one measurable tumor focal point;
•Karnofsky [2] score 50 or more;
•Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
•The expected survival time is greater than 3 months;
•Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

排除标准

•Serious cardiac insufficiency, left ventricular ejection fraction<50;
•Has a history of severe pulmonary function damaging;
•Merging other 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);
•Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
•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.