NCT04440436招募中1 期
Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年6月4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
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR) at 90 days
研究概览
简要总结
This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.
详细描述
This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
- •CD20 positive patients undergo corresponding targeted therapy.
- •Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
- •≥ 18 years old.
- •The expected survival period is more than 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up
- •Participate voluntarily in this experiment and sign the informed consent.
排除标准
- •The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
- •Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
- •Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
- •Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
- •Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
- •Subject has used any gene therapy products before.
- •Subject with a history of epilepsy or other central nervous system diseases.
- •Active Hepatitis B Virus or Hepatitis C Virus infections
- •The subject with other tumors in the past 5 years.
- •Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.
研究组 & 干预措施
IM19 CAR-T cells
Experimental
IM19 CAR-T cells be administrated in two dose level
干预措施: IM19 CAR-T Cells (Drug)
结局指标
主要结局
Objective Response Rate(ORR) at 90 days
时间窗: 90 days
The primary endpoint was ORR 90 days after IM19 infusion
次要结局
未报告次要终点
研究者
研究点 (1)
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