中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1800019618
最近更新日期： Date of Last Refreshed on：	2018-11-19 23:44:29
注册时间： Date of Registration：	2018-11-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	肿瘤相关抗原特异性T细胞治疗血液系统恶性肿瘤的临床研究
Public title：	Clinical study of tumor-associated antigen-specific T cells in the treatment of hematological malignancies
注册题目简写：
English Acronym：
研究课题的正式科学名称：	肿瘤相关抗原特异性T细胞治疗血液系统恶性肿瘤的临床研究
Scientific title：	Clinical study of tumor-associated antigen-specific T cells in the treatment of hematological malignancies
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	施磊	研究负责人：	王兴兵
Applicant：	Lei Shi	Study leader：	Xingbing Wang
申请注册联系人电话： Applicant telephone：	+86 18056095418	研究负责人电话： Study leader's telephone：	+86 18056095418
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	18056095418@qq.com	研究负责人电子邮件： Study leader's E-mail：	18056095418@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	安徽安科生物工程（集团）股份有限公司	研究负责人通讯地址：	安徽省合肥市庐江路17号
Applicant address：	Anhui Anke Biotechnology (Group) Co., Ltd.	Study leader's address：	17 Lujiang Road, Luyang District, Hefei, Anhui, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	安徽安科生物工程（集团）股份有限公司
Applicant's institution：	Anhui Anke Biotechnology (Group) Co., Ltd.
研究负责人所在单位：	中国科技大学附属第一医院（安徽省立医院）
Affiliation of the Leader：	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2017伦审第216号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	安徽省立医院临床试验伦理委员会
Name of the ethic committee：	Anhui Provincial Hospital Clinical Trial Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	1990-01-01 00:00:00
伦理委员会联系人：	陈梅男
Contact Name of the ethic committee：	Meinan Chen
伦理委员会联系地址：	安徽省合肥市庐江路17号
Contact Address of the ethic committee：	17 Lujiang Road, Luyang District, Hefei, Anhui, China
伦理委员会联系人电话： Contact phone of the ethic committee：		伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

中国科技大学附属第一医院（安徽省立医院）

Primary sponsor：

The first affliated hospital of USTC (Anhui provincial hospital)

研究实施负责（组长）单位地址：

安徽省合肥市庐江路17号

Primary sponsor's address：

17 Lujiang Road, Luyang District, Hefei, Anhui, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	安徽	市(区县)：	合肥
Country：	China	Province：	Anhui	City：	Hefei
单位(医院)：	安徽安科生物工程（集团）股份有限公司	具体地址：	合肥市长江西路669号高新区海关路K-1
Institution hospital：	Anhui Anke Biotechnology (Group) Co., Ltd.	Address：	669 Changjiang Road West, Hefei

经费或物资来源：

自筹经费

Source(s) of funding：

Self-financing

研究疾病：

白血病、淋巴瘤、多发性骨髓瘤、骨髓异常增生综合征

Target disease：

Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome

研究疾病代码：

Target disease code：

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

治疗新技术临床试验

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂

Study design：

Single arm

研究目的：

评价肿瘤相关抗原特异性T细胞治疗血液系统恶性肿瘤的有效性、安全性。

Objectives of Study：

To evaluate the efficacy and safety of tumor-associated antigen-specific T cells in the treatment of hematological malignancies.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Multiple Myeloma:
(1) Aged 18-80 years, race and gender not a concern;
(2) Must be a high-risk patient and have received at least one treatment plan;
(3) When collecting cells, patients do not receive systemic chemotherapy within 2 weeks (except lenalidomide, thalidomide or immunological checkpoint inhibitors such as CTLA4 and / or PD-1 / PD-L1 inhibitor) or not receiving radiotherapy within 3 weeks;
(4) ECOG PS of 0 to 2;
(5) hemoglobin > 80g / L (may be after transfusion);
(6) Left ventricular ejection fraction (LVEF)≥40%;
(7) Expected survival time > 6 weeks;
(8) serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
(9) serum AST and ALT ≤ 5 times the normal value;
(10) The patient has the ability to self-knowledge and can sign an informed consent form;
2. Lymphoma:
(1) Hodgkin or non-Hodgkin's lymphoma patients with relapsed/refractory or at high risk of recurrence, or lymphomas with a second malignancy;
(2) Aged 14-80 years old male and female;
(3) When collecting cells, the patient does not receive systemic chemotherapy (including rituximab) within 2 weeks or not receiving radiotherapy within 3 weeks;
(4) ECOG PS of 0 to 2;
(5) Hemoglobin > 80g / L (may be after transfusion);
(6) Left ventricular ejection fraction (LVEF)≥40%;
(7) Expected survival time > 6 weeks;
(8) serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
(9) serum AST and ALT ≤ 5 times the normal value;
(10) The patient has the ability to self-knowledge and can sign an informed consent form;
(11) The guardian of the child patient agrees to sign the informed consent form.
3. Acute Leukemia and MDS:
(1) patients with relapsed/refractory or high risk of relapse (including acute lymphocytic leukemia, acute myeloid leukemia, acute mixed cell leukemia) or high-risk myelodysplastic syndrome;
(2) Patients need to have indicators for testing or assessing disease when they are enrolled, including detection of minimal residual disease (MRD) using immunophenotyping, cytogenetics or PCR;
(3) Aged 14-80 years old male and female;
(4) When collecting cells, the patient does not receive systemic chemotherapy within 2 weeks or does not receive radiotherapy within 3 weeks;
(5) ECOG PS of 0 to 2;
(6) Hemoglobin > 80g / L (may be after transfusion);
(7) Left ventricular ejection fraction (LVEF)≥40%;
(8) Expected survival time > 6 weeks;
(9) Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
(10) Serum AST and ALT ≤ 5 times the normal value;
(11) The patient has the ability to know and can sign an informed consent form.

排除标准：

1.多发性骨髓瘤
排除标准：
1)怀孕或哺乳期妇女；
2)严重的活动性感染患者；
3)因病情需要在细胞采集或输注时全身使用糖皮质激素的患者；
4)HIV感染者；
5)非原发病引起的中性粒细胞绝对计数< 750/微升或血小板计数< 50,000/微升。
6)凝血参数异常（PT大于15秒，PTT大于40秒，和/或INR大于1.5）。

2.淋巴瘤
排除标准：
1)怀孕或哺乳期妇女；
2)严重的活动性感染患者；
3)因病情需要在细胞采集或输注时全身使用糖皮质激素的患者；
4)HIV感染者；
5)非原发病引起的中性粒细胞绝对计数< 750/微升或血小板计数< 50,000/微升。
6)凝血参数异常（PT大于15秒，PTT大于40秒，和/或INR大于1.5）。

3.急性白血病和MDS
排除标准：
1)怀孕或哺乳期妇女；
2)严重的活动性感染患者；
3)因病情需要在细胞采集或输注时全身使用糖皮质激素的患者；
4)合并2-4度急性或广泛性慢性GVHD者，接受GVHD治疗者；
5)HIV感染者；
6)非原发病引起的血小板计数< 50,000/微升；
7)采集细胞时，患者1周前接受全身化疗或放疗者；
8)凝血参数异常（PT大于15秒，PTT大于40秒，和/或INR大于1.5）；
9)在筛选入选后28天内接受ATG或Campath或其他免疫抑制性T细胞单克隆抗体的患者。

Exclusion criteria：

1. Multiple myeloma:
(1) pregnant or lactating women;
(2) Patients with severe active infections;
(3) Patients who require systemic glucocorticoids during cell collection or infusion due to their condition;
(4) HIV-infected;
(5) Absolute neutrophil counts caused by non-primary disease < 750 / microliter or platelet count < 50,000 / microliter;
(6) Abnormal blood coagulation parameters (PT > 15 seconds, PTT > 40 seconds, and / or INR > 1.5).
2. Lymphoma:
1）pregnant or lactating women;
(2) Patients with severe active infections;
(3) Patients who require systemic glucocorticoids during cell collection or infusion due to their condition;
(4) HIV-infected ;
(5) Absolute neutrophil counts caused by non-primary disease < 750 / microliter or platelet count < 50,000 / microliter;
(6) Abnormal blood coagulation parameters (PT > 15 seconds, PTT > 40 seconds, and / or INR > 1.5).
3. Acute Leukemia and MDS:
(1) pregnant or lactating women;
(2) Patients with severe active infections;
(3) Patients who require systemic glucocorticoids during cell collection or infusion due to their condition;
(4) Patients who have 2-4 degrees of acute or extensive chronic GVHD or treated with GVHD;
(5) HIV-infected;
(6) Platelet count caused by non-primary disease < 50,000 / μL;
(7) When collecting cells, the patient received systemic chemotherapy or radiotherapy 1 week ago;
(8) Absolute neutrophil counts caused by non-primary disease < 750 / microliter or platelet count < 50,000 / microliter;
(9) Patients who received ATG or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening.

研究实施时间：

Study execute time：

从 From 2018-12-30 00:00:00至 To 2020-07-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2019-01-01 00:00:00 至 To 2020-07-01 00:00:00

干预措施：

Interventions：

组别：	白血病、淋巴瘤、多发性骨髓瘤、骨髓异常增生综合征	样本量：	60
Group：	Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome	Sample size：	60
干预措施：	回输细胞	干预措施代码：
Intervention：	Cell transfusion	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

测量指标：

Outcomes：

指标中文名：	完全缓解率	指标类型：	主要指标
Outcome：	complete response	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	部分缓解率	指标类型：	次要指标
Outcome：	partial response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	14	岁 years
最大 Max age	80	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	试验结束后1年内在专业期刊或网站发布
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Published in professional journals or websites within 1 year after the trial
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	所有原始记录、实验室检查结果应完整保存。研究中的任何观察、检查结果均应及时、准确、完整、规范、真实地记录于CRF表中。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	All original records and laboratory test results should be kept intact. Any observations and inspection results in the study shall be recorded in the CRF form in a timely, accurate, complete, standardized and authentic manner.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2018-11-19 23:44:29