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An single-center, open-label and case control clinical study to evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection
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注册号:

Registration number:

ChiCTR-OPN-17013068 

最近更新日期:

Date of Last Refreshed on:

2017-10-21 

注册时间:

Date of Registration:

2017-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Anti-gp120 CAR-T细胞治疗合并HAART方案治疗对HIV-1感染初治受试者安全性和有效性的单中心、开放、对照临床研究 

Public title:

An single-center, open-label and case control clinical study to evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection 

注册题目简写:

嵌合抗原受体修饰 T 细胞(CAR-T)临床研究 

English Acronym:

CAR-T clinical study 

研究课题的正式科学名称:

Anti-gp120 CAR-T细胞治疗合并HAART方案治疗对HIV-1感染初治受试者安全性和有效性的单中心、开放、对照临床研究 

Scientific title:

An single-center, open-label and case control clinical study to evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection 

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:

顾潮江/刘慧宁/阮连国/聂琦 

研究负责人:

张同存/张定宇 

Applicant:

Chaojiang Gu/Huining Liu/Lianguo Ruan/Qi Nie 

Study leader:

Tongcun Zhang/Dingyu Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15802753951/18001263855/15807145269/13995676217 

研究负责人电话:

Study leader's telephone:

+86 027-87570668/027-85509836 

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:

Guchaojiang@wust.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhangtongcun@wust.edu.cn 

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:

武汉市东湖新技术开发区高新二路388号光谷国际生物医药企业加速器一期1号厂房40号/武汉市东西湖区银潭路1号 

研究负责人通讯地址:

武汉市东湖新技术开发区高新二路388号光谷国际生物医药企业加速器一期1号厂房40号/武汉市东西湖区银潭路1号 

Applicant address:

388 Second Gaoxin Road, Donghu New Technology Development Zone, Wuhan, Hubei, China/NO.1, yintan road,Dongxihu Avenue, Wuhan, Hubei, China 

Study leader's address:

388 Second Gaoxin Road, Donghu New Technology Development Zone, Wuhan, Hubei, China/NO.1, yintan road,Dongxihu Avenue, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430000 

研究负责人邮政编码:

Study leader's postcode:

430000 

申请人所在单位:

武汉云谷生物医药科技有限公司/武汉市金银潭医院 

Applicant's institution:

YunGu Biomedical Technology Co., Ltd. /Jinyintan Hospital of WuHan 

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:

KY-AZ-2017-01 

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:

武汉市传染病医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Wuhan Infectious Disease Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-18 

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:

武汉市金银潭医院 

Primary sponsor:

Jinyintan Hospital of WuHan 

研究实施负责(组长)单位地址:

武汉市东西湖区银潭路1号 

Primary sponsor's address:

1 Yintan Road, Dongxihu Avenue, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉云谷生物医药科技有限公司

具体地址:

武汉市东湖新技术开发区高新二路388号光谷国际生物医药企业加速器一期1号厂房40号

Institution
hospital:

YunGu Biomedical Technology Co., Ltd.

Address:

388 Second Gaoxin Road, Donghu New Technology Development Zone, Wuhan, Hubei, China/NO.1, yintan road,Dongxihu Avenue, Wuhan, Hubei, China

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市金银潭医院

具体地址:

武汉市东西湖区银潭路1号

Institution
hospital:

Jinyintan Hospital of WuHan

Address:

1 Yintan Road, Dongxihu Avenue, Wuhan, Hubei, China

经费或物资来源:

武汉云谷生物医药科技有限公司 

Source(s) of funding:

YunGu Biomedical Technology Co., Ltd.  

研究疾病:

HIV-1感染 

Target disease:

HIV-1 infection disease 

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:

探索性研究/预试验 

Study phase:

研究目的:

评价Anti-gp120 CAR-T细胞治疗合并HAART方案治疗对HIV-1感染初治受试者的安全性和有效性 

Objectives of Study:

To evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. ≥18岁,且≤65岁。 2. 确认HIV-1感染。 3. HIV病毒载量范围在1x104-1x106cp/mL之间。 4. 外周CD4+T细胞数量>200个/ul的的感染者。 5. 患者重要组织器官功能良好,相关各项指标满足以下要求: 肝功能:ALT/AST<2倍正常值上限(ULN)且总胆红素≤34.2μmol/L; 肾功能:内生肌酐清除率在>80ml/min; 指脉氧:SpO2≥95%; 心功能:左室射血分数(LVEF)≥40%; 血常规示白细胞、血小板、血红蛋白各项指标未见显著异常者。 头颅CT及脑电图未见异常者。 6. 有能力了解研究相关内容并愿意签署书面知情同意书的患者。 

Inclusion criteria

1. aged 18-65 years; 2. Confirmed HIV-1 infection; 3. HIV viral load between 1x104 and 1x106cp/mL; 4. CD4+T cell count>200/ul; 5. Multiple organ function assessment: ALT /AST<2 normal value and total bilirubin < 34.2μmol/L; creatinine clearance>80ml/min; SPO2>=95%; LVEF>40%; blood routine shows WBCPLTHb are normal; head CT and EEG are normal 6. have the ability to understand the study and C34Voluntary participation in the clinical trials and sign the informed consent. 

排除标准:

1. 接受过任何HIV抗病毒治疗的患者。 2. 在筛选90天内使用过免疫调节剂,细胞因子或生长刺激因子如全身性皮质类固醇,环孢菌素,甲氨蝶呤,硫唑嘌呤,抗CD25 抗体,IFN,白细胞介素2(IL-2);香豆素,华法林或其他香豆素衍生物等抗凝药物的患者。 3. 在入组前90天内接受任何静脉血液制品,免疫球蛋白或造血生长因子的患者。 4. 患者在入组后1年内不能保证采取有效的避孕措施(安全套或避孕药等)。 5. 处于怀孕期(尿妊娠试验阳性)或哺乳期的女性。 6. 患有恶性肿瘤、自身免疫疾病、没有得到控制的糖尿病、高血压及心肝肺肾功能不正常者或有其他严重的器质性疾病者。 7. 患有需要治疗的其它全身性活动性感染,包括梅毒、活动性结核,临床活动性甲、乙、丙型肝炎患者。 8. 患有精神疾病者。 9. 患者在入组前三个月内参加过或者目前正在参加其他临床试验。 10. 酗酒、药物成瘾者。 11. 同时接受HAART治疗的禁用药物者。 12. 患者为过敏体质,对抗体或细胞因子等大分子生物药物过敏。 13. 任何经研究者判定不适合参加本研究的。 

Exclusion criteria:

1. haven't received HIV antiretroviral therapy; 2. Within 90 days of the screening, received the treatment of immunomodulatory, cytokines or growth stimulating factors, such as systemic corticosteroids, Systemic corticosteroids, cyclosporin, azathioprine, methotrexate, anti CD25 antibody, IFN, IL-2; coumarin, warfarin or other anticoagulants like coumarin cerivatives; 3. Within 90 days befor enrolled, reveived the treatment of venous blood products, immunoglobulin, hemopoietic growth factor; 4. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 5. Pregnancy and nursing females; 6. With malignant tumor,autoimmune diseases; With uncontrolled diabetes,hypertension; With cardiac,lung, liver, renal insufficiency, or with other serious organic disease; 7. With systemic active infections that need treatments, including syphilis, active tuberculosis, clinically active hepatitis A, B and C; 8. History of mental disorders; 9. Participation or be enrolling in an investigational research study within 3 months before enrolled; 10. Alcohlim or drug abuse; 11. Received concomitant medication prohibited for HAART treatment; 12. Allergic to any cytokines or antibodies; 13. Other situations we think improper for the research. 

研究实施时间:

Study execute time:

From2017-05-08To 2018-12-31 

干预措施:

Interventions:

组别:

A

样本量:

3

Group:

A

Sample size:

干预措施:

CAR-T细胞治疗

干预措施代码:

Intervention:

CAR-T Cells treatment

Intervention code:

组别:

C

样本量:

3

Group:

C

Sample size:

干预措施:

非清髓性预处理+CAR-T细胞治疗

干预措施代码:

Intervention:

Non- myeloablative pre-treated and Car-T cells treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市金银潭医院 

单位级别:

三级甲等 

Institution
hospital:

Jinyintan Hospital of WuHan  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

不良事件发生率

指标类型:

主要指标 

Outcome:

Adverse effects rate

Type:

Primary indicator 

测量时间点:

签署知情同意书至随访结束

测量方法:

Measure time point of outcome:

from the ICF design to the last follow up

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 18 years
最大 Max age 65 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):

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

NO

盲法:

Blinding:

NO

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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:

设计有临床专用CRF表,专人进行纸质记录,并录入数据库,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,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 data base. The medical records with the signature of the doctor in charge are all in print edition, which will be saved in the hospital.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-10-21
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