Today is 2020-10-31

An open single center single arm clinical study of through infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiply myeloma
download

注册号:

Registration number:

ChiCTR-OIC-17011272 

最近更新日期:

Date of Last Refreshed on:

2017-05-01 

注册时间:

Date of Registration:

2017-05-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

序贯输注抗BCMA CAR-T及抗CD19 CAR-T治疗复发、难治多发性骨髓瘤的安全性和有效性的单中心、开放、单臂临床研究 

Public title:

An open single center single arm clinical study of through infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiply myeloma  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

序贯输注抗BCMA CAR-T及抗CD19 CAR-T治疗复发、难治多发性骨髓瘤的安全性和有效性的单中心、开放、单臂临床研究 

Scientific title:

An open single center single arm clinical study of through infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiply myeloma  

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:

曹江 

研究负责人:

徐开林 

Applicant:

Jiang Cao 

Study leader:

Kailin Xu 

申请注册联系人电话:

Applicant telephone:

+86 13852432263 

研究负责人电话:

Study leader's telephone:

+86 0516 85802398 

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:

zimu05067@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lihmd@163.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:

江苏省徐州市淮海西路99号血液科 

研究负责人通讯地址:

江苏省徐州市淮海西路99号 

Applicant address:

99 West Huaihai Road, Xuzhou, Jiangsu, China 

Study leader's address:

99 West Huaihai Road, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院 

Applicant's institution:

The Affiliated Hospital of Xuzhou Medical University 

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:

XYFY2017-KL013-01 

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:

徐州医学院附属医院临床试验伦理委员会 

Name of the ethic committee:

The Clinical Research Ethics Committee of the Affiliated Hospital of Xuzhou Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-06 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

徐州医科大学附属医院 

Primary sponsor:

The Affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市淮海西路99号 

Primary sponsor's address:

99 West Huaihai Road, Xuzhou, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

徐州医科大学附属医院

具体地址:

江苏省徐州市淮海西路99号

Institution
hospital:

The Affiliated Hospital of Xuzhou Medical University

Address:

99 West Huaihai Road, Xuzhou, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

多发性骨髓瘤 

Target disease:

Multiple Myeloma 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

评价靶向BCMA的CAR-T细胞与靶向CD19的CAR-T细胞联合治疗复发、难治多发性骨髓瘤的安全性及有效性 

Objectives of Study:

To evaluate the safety and efficacy of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiply myeloma  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

[1] 年龄为18~70岁周岁; [2] 预计生存期>12周; [3] 经体格检查、病理学检查 、实验室检查和影像学确诊为多发性骨髓瘤; [4] 多发性骨髓瘤化疗失败的患者; [5] 多发性骨髓瘤复发的患者; [6] ALT、AST< 3倍正常; [7] 胆红素< 2.0mg/dl; [8] 生存质量评分(KPS)>50%; [9] 病人无严重的肝、肾、心脏等疾病; [10] 经自体干细胞、异体干细胞移植治疗失败; [11]不适合干细胞移植条件或由于条件限制放弃移植; [12]自愿尝试CAR-T治疗B细胞恶性血液病患者; [13]可以静脉取血,没有其他白细胞采集术禁忌症; [14]能理解并自愿签署书面知情同意书。 

Inclusion criteria

1. Aged 18-70 years; 2. Expected survival beyond 12 weeks; 3. Patients with multiply myeloma diagnosed by pathology and histology; 4. Patients could not achieve complete response after chemotherapy; 5. Patients with with relapsed disease after chemotherapy; 6. ALT /AST<3 normal value; 7. Bilirubin < 2.0 mg/dl; 8. Karnofsky score >50; 9. Patients without severe liver, kidney, heart disease; 10. Patients with relapsed disease after hematopoietic stem cell transplantation; 11. Not eligible or appropriate for hematopoietic stem cell transplantation; 12. Voluntary participation in the clinical trials; 13. Venous blood could be obtained or no contraindications for white blood collection; 14. Sign the consent form.  

排除标准:

[1]怀孕或哺乳期妇女,或半年内有妊娠计划的妇女; [2]传染性疾病(如HIV、活动性结核等); [3]活跃的乙肝或丙肝感染; [4]可行性评估筛查证明靶向淋巴细胞的转染< 10%或者在CD3/CD28共同刺激下扩增不足(< 5倍); [5]生命体征不正常,以及不能配合检查者; [6]有精神或心理疾病不能配合治疗及疗效评估者; [7]高度过敏体质或有严重过敏史,尤其对IL-2过敏者; [8]全身感染或局部严重感染需抗感染治疗受试者; [9]合并心、肺、脑、肾等重要脏器的功能障碍; [10]严重自身免疫性疾病受试者; [11]医生认为还存在有其他原因不能纳入治疗者。  

Exclusion criteria:

1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected; 3. Active hepatitis B or hepatitis C infection; 4. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 5. Patients with abnormal vital signs or could not cooperate with inspectors; 6. History of mental disorders; 7. Highly allergic constitution or severe allergies, especially allergic to IL-2; 8. Systemic infection or serious infections should be local anti-infection treatment; 9. With heart, lung, brain, kidney and other important organ dysfunction; 10. Presence of severe autoimmune disease; 11. Other situations we think improper for the research.  

研究实施时间:

Study execute time:

From2017-04-01To 2020-03-31 

征募观察对象时间:

Recruiting time:

From2017-05-01To 2020-03-31 

干预措施:

Interventions:

组别:

1

样本量:

20

Group:

1

Sample size:

干预措施:

CAR-T细胞

干预措施代码:

Intervention:

CAR-T cells

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A hospital 

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 remission rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

Progression Free Survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

Overall Survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

次要指标 

Outcome:

Safety

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:

标本中文名:

骨髓

组织:

Sample Name:

Bone marrow

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

非随机

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

Non-randomized

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

试验完成后12个月内公开,采用临床试验公共管理平台ResMan向公众开放查询

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data will be published in the public management platform of clinical trials ResMan after the Study Completed 12 mouths

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:

本课题设计有临床专用CRF表,专人进行纸质记录,并录入Excel电子表格,保存于研究者处;患者临床病史记录为纸质版,主管医师签字后保存于医院病案室,以备查阅。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Each patient are required to fill one CRF table, All the CRF tables saved by researchers and will be saved by using EXCEL software. The medical records with the signature of the doctor in charge are all in print edition, which will be saved in the medical-record department of hospital.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-05-01
return list