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输注Anti-CD22 CAR-T治疗复发/难治/高危B淋巴细胞肿瘤的安全性和有效性的单中心、开放、单臂临床研究
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注册号:

Registration number:

ChiCTR1800019385 

最近更新日期:

Date of Last Refreshed on:

2018-11-08 

注册时间:

Date of Registration:

2018-11-08 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

输注Anti-CD22 CAR-T治疗复发/难治/高危B淋巴细胞肿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-label, single-center and single-arm clinical study for infusion of anti-CD22 CAR-T cells for patients with relapsed or refractory B-cell malignancies  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

输注Anti-CD22 CAR-T治疗复发/难治/高危B淋巴细胞肿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-label, single-center and single-arm clinical study for infusion of anti-CD22 CAR-T cells for patients with relapsed or refractory B-cell 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:

周晓曦 

研究负责人:

周剑峰 

Applicant:

Zhou Xiaoxi 

Study leader:

Zhou Jianfeng 

申请注册联系人电话:

Applicant telephone:

+86 027-83663609 

研究负责人电话:

Study leader's telephone:

+86 027-83663609 

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:

cello316@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhougene@medmail.com.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:

武汉市硚口区解放大道1095号 

研究负责人通讯地址:

武汉市硚口区解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430030 

研究负责人邮政编码:

Study leader's postcode:

430030 

申请人所在单位:

华中科技大学同济医学院附属同济医院 

Applicant's institution:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

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:

TJ-IRB20160914 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-09-14 

伦理委员会联系人:

常慕君 

Contact Name of the ethic committee:

Chang Mujun 

伦理委员会联系地址:

武汉市硚口区解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, 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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

研究实施负责(组长)单位地址:

武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Qiaokou District, 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):

华中科技大学同济医学院附属同济医院

具体地址:

武汉市硚口区解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Qiaokou District, Wuhan

经费或物资来源:

武汉波睿达生物科技有限公司 

Source(s) of funding:

Wuhan Bio –Raid Biotechnology Co.,Ltd.  

研究疾病:

B淋巴细胞肿瘤 

Target disease:

B-cell malignancies 

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:

评价输注Anti-CD22 CAR-T治疗复发/难治/高危B淋巴细胞肿瘤的安全性 

Objectives of Study:

to evaluate the security of anti-CD22 CAR-T therapy for relapsed, refractory and high-risk B-cell malignancies 

药物成份或治疗方案详述:

Anti-CD22 CAR-T 

Description for medicine or protocol of treatment in detail:

Anti-CD22 CAR-T 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 患者或其法定监护人自愿参加并签署知情同意书; 2. 年龄为18~70岁(含18和70岁)的男性或者女性患者; 3. 经病理学和组织学检查确诊为CD22+细胞肿瘤,患者目前无有效治疗方案,如化疗或经造血干细胞移植治疗后复发;或者患者自愿选择输注抗CD22 CAR-T细胞作为第一治疗方案。 4. B细胞肿瘤包括以下3类: (1) B细胞急性淋巴细胞白血病(B-ALL); (2) 惰性B细胞淋巴瘤(CLL、FL、MZL、LPL、HCL); (3) 侵袭性B细胞淋巴瘤(DLBCL、BL、MCL)。 5. 受试者: (1) 主要治疗后仍有残余病灶,且不适合接受HSCT(auto/allo-HSCT); (2) CR1 后出现复发,且不适合接受HSCT(auto/allo-HSCT); (3) 具有高危因素的患者; (4) 经造血干细胞移植或细胞免疫治疗后复发或者疾病无缓解。 6. 具有可测量或者可评价的病灶; 7. 患者主要组织器官功能良好: (1) 肝功能:ALT/AST<3倍正常值上限(ULN)且总胆红素≤34.2μmol/L; (2) 肾功能:肌酐<220μmol/L; (3) 肺功能:室内氧饱和度≥95%; (4) 心功能:左心室射血分数(LVEF)≥40%。 8. 患者入组前4周内未接受任何化疗、放疗、免疫治疗(如免疫抑制药物)等抗癌治疗,且其既往治疗相关毒性反应在入组时已恢复至≤1级(脱发等低级毒性除外); 9. 患者外周浅静脉血流通畅,可满足静脉滴注需求; 10. 患者ECOG评分≤2,预计生存时间≥3个月者。 

Inclusion criteria

1. Voluntary participation in the clinical trials and sign the informed consent; 2. male and female aged 18 to 70 years; 3. Patients with CD22 leukemia or lymphoma diagnosed by pathology and histology, and have no effective treatment by now, including patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept through infusion of anti-CD22 CAR-T cell therapy as the salvage therapy; 4. types of B cell malignancy are included: B cell Acute lymphoblastic leukemia; Indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B cell lymphoma (DLBCL, BL, MCL); 5. Patients enrolled in are meeting the following criteria: (1) Present residual disease after main therapy but not eligible for HSCT; (2) Relapse after CR1 but not eligible for HSCT; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after HSCT; (5) Patients with measurable lesions; 6. With observable tumor foci; 7. Multiple organ function assessment: Creatinine < 2.5 mg/dl; Aspartate transaminase-alanine transaminase ratio < 3x normal; SiO2>=95%; Bilirubin < 2.0 mg/dl; LVEF>40%; 8. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy(immune suppressive drugs treatment) within 4 weeks of screening. 9. Adequate venous access for apheresis; 10. ECOG score <=2, Estimated survival of >=3 months. 

排除标准:

1. 处于怀孕期(尿/血妊娠试验阳性)或者哺乳期的女性; 2. 近1年内有受孕计划的男性或者女性; 3. 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); 4. 患者入组前4周内患有无法控制的感染疾病; 5. 活动性乙型/丙型病毒肝炎; 6. HIV感染患者; 7. 患有严重的自身免疫疾病或者免疫缺陷疾病; 8. 患者为过敏体质,对抗体或者细胞因子等大分子生物药物过敏; 9. 患者在入组前6周内参加过其他临床试验; 10. 患者入组前4周内系统性使用激素(使用吸入激素患者除外); 11. 患有精神疾病; 12. 患者存在药物滥用/成瘾; 13. 经研究者判断,患者存在其他不适宜入组情况。 

Exclusion criteria:

1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 4. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening; 5. active HBV/HCV infected; 6. any human immunodeficiency virus (HIV) infection; 7. History of accepting systemic steroids treatments within 4 weeks; 8. Allergic to any cytokines or antibodies; 9. Participation in an investigational research study within 6 weeks before enrolled; 10. History of accepting systemic steroids treatments within 4 weeks; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.  

研究实施时间:

Study execute time:

From2016-09-14To 2020-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

50

Group:

Case series

Sample size:

干预措施:

Anti-CD20 CAR-T细胞治疗

干预措施代码:

Intervention:

Chimeric Antigen Receptor T-Cell Immunotherapy

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):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

安全性

指标类型:

主要指标 

Outcome:

safety

Type:

Primary 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:

外周血

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:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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 6 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长征医院病案室,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 data base. 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 Wuhan Tongji hospital.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-11-08
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