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Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

2019年2月13日 更新者:Wenbin Qian、First Affiliated Hospital of Zhejiang University

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

60

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Zhejiang
      • Hangzhou、Zhejiang、中国、310000
        • The First Affiliated Hospital of Zhejiang University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age≥18 years, male or female;
  2. Karnofsky≥60%;
  3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
  4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
  5. Patients have had more than 2 combined chemotherapy regimens;
  6. Creatinin <2.5mg/dL;ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL;
  7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
  8. Patient that could understand and is willing to sign the written consent;
  9. Fertile female patient should be willing to take contraceptive measures.
  10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria:

  1. Patients who need ≥15mg prednisone daily due to any cause;
  2. Patients with autoimmune disease and need immunosuppressor treatment;
  3. Serum creatinin>2.5 mg/dL;serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
  4. FEV1<2 L,diffusion capacity for carbon monoxide of lung (DLCO) <40%;
  5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%;
  6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
  7. Patients that have previously received gene therapy of any kind;
  8. Obvious clinical encephalopathy or novel neuron function damage;
  9. Patients with active infection;
  10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
  11. Patients who had allergic history to agents of the similar structure as CAR-T;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CAR-T treatment
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
complete remission rate
大体时间:every 3 months until 20 months after the last patient's enrollment
complete remission rate after treated by CAR-T therapy
every 3 months until 20 months after the last patient's enrollment

次要结果测量

结果测量
措施说明
大体时间
progression free survival
大体时间:from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
from date of inclusion to date of progression, relapse, or death from any cause
from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
overall survival
大体时间:20 months after the last patient's enrollment
from the date of inclusion to date of death, irrespective of cause
20 months after the last patient's enrollment
adverse events
大体时间:from the date of the start of treatment to 20 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
from the date of the start of treatment to 20 months after last patient's enrollment
duration of the modified T cells by CAR-T in the patients
大体时间:from the date of re-transfusison to 20 months after last patient's enrollment
time from re-transfusion to date when the modified T cells become non-detectable.
from the date of re-transfusison to 20 months after last patient's enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月15日

初级完成 (实际的)

2019年1月13日

研究完成 (预期的)

2019年7月30日

研究注册日期

首次提交

2017年8月20日

首先提交符合 QC 标准的

2017年8月21日

首次发布 (实际的)

2017年8月22日

研究记录更新

最后更新发布 (实际的)

2019年2月15日

上次提交的符合 QC 标准的更新

2019年2月13日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • lymphoma center Q002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All the data would be available on the corresponding website of the leading research center.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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