Today is 2020-12-02

Novel coronavirus pneumonia (COVID-19) loaded autologous dendritic cell trial
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注册号:

Registration number:

ChiCTR2000034076 

最近更新日期:

Date of Last Refreshed on:

2020-06-22 

注册时间:

Date of Registration:

2020-06-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19) 自体DC细胞临床研究 

Public title:

Novel coronavirus pneumonia (COVID-19) loaded autologous dendritic cell trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19) S-Vax负载自体DC细胞的安全性及免疫原性的研究 

Scientific title:

A safety and immune response trial of novel coronavirus pneumonia (COVID-19) S-Vax loaded autologous dendritic cells 

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:

向晓宇 

研究负责人:

马胜军 

Applicant:

Xiaoyu Xiang 

Study leader:

Shengjun Ma 

申请注册联系人电话:

Applicant telephone:

+86 13521263700 

研究负责人电话:

Study leader's telephone:

+86 13346256336 

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:

xiangxiaoyu@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

msj6336@126.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:

北京市大兴区亦庄经济技术开发区科创六街88号2号楼107室 

研究负责人通讯地址:

山东省聊城市东昌府区东昌西路67号 

Applicant address:

Room 107, Building 2, 88 KeChuang 6th ST, Daxing District, Beijing, China 

Study leader's address:

67 DongChang Road West, Dongchangfu Distric, Liaocheng, Shandong, 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:

北京蒂尔斯细胞技术有限公司 

Applicant's institution:

Beijing TIL Therapeutics 

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:

2020009 

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:

聊城市人民医院医学伦理委员会 

Name of the ethic committee:

Liaocheng People's Hospital Ethnic Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-14 

伦理委员会联系人:

马伟建 

Contact Name of the ethic committee:

Weijian Ma 

伦理委员会联系地址:

山东省聊城市东昌府区东昌西路67号 

Contact Address of the ethic committee:

67 DongChang Road West, Dongchangfu Distric, Liaocheng, Shandong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13346258883 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

maweijian001@163.com 

研究实施负责(组长)单位:

北京蒂尔斯细胞技术有限公司 

Primary sponsor:

Beijing TIL Therapeutics 

研究实施负责(组长)单位地址:

北京市大兴区亦庄经济技术开发区科创六街88号2号楼107室 

Primary sponsor's address:

Room 107, Building 2, 88 KeChuang 6th ST, Daxing District, Beijing, 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):

山东

市(区县):

聊城市

Country:

China

Province:

Shandong

City:

Liaocheng

单位(医院):

聊城市人民医院

具体地址:

山东省聊城市东昌府区东昌西路67号

Institution
hospital:

Liaocheng People's Hospital

Address:

67 Dongchang Road West, Dongchangfu District

经费或物资来源:

北京蒂尔斯细胞技术有限公司 

Source(s) of funding:

Beijing TIL Therapeutics 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评价COVID19 S-Vax负载自体DC细胞在人体的安全性及免疫原性。 

Objectives of Study:

To evaluate the safety and immune response of COVID19 S-Vax loaded autologous monocyte-derived dendritic cells in human 

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 年龄在18至60岁之间(包括边界值)的自愿受试者; 2 能够提供知情同意书; 3 同意按照协议采集静脉血及接受随访; 4 血常规:血红蛋白(Hgb)≥ 110 g/L,白细胞计数(WBC)≥4×109/L,中性粒细胞绝对数(ANC)≥2×109/L,单核细胞绝对值(monocyte)≥ 0.2×109/L,血小板计数(PLT)≥ 100×109/L; 5 ECOG(Eastern Cooperative Oncology Group)评分0或1; 6 血生化全项:丙氨酸转移酶(ALT)< 40 IU/L,门冬氨酸转移酶(AST)< 45 IU/L; 7 女性受试者妊娠检测为阴性,并同意在参加研究的1年内能够采取有效避孕措施; 8 男性受试者同意在参加研究的1年内能采取有效避孕措施。 

Inclusion criteria

1. Aged between 18 and 60 years old; 2. Be able to understand and sign informed consent form; 3. Agree to collect blood samples during the study and follow-up period; 4. Blood test satisfy: Hemoglobin>=110 g/LWhite blood cell >=4x10^9/L, absolute neutrophil count >=2x10^9/L; monocyte>=0.2x10^9/L; PLT>=100x10^9/L; 5. ECOG(Eastern Cooperative Oncology Group)score 0 or 1; 6. Blood biochemistry: alanine aminotransferase (ALT) < 40 IU/Laspartate aminotransferase (AST) < 45 IU/L; 7. Women of reproductive potential must have a negative pregnancy test and agree to take effective birth control within one year during the study; 8. Male participants agree to practice birth control within one year during the study. 

排除标准:

1 过敏体质者:对疫苗有过敏反应或严重过敏反应(例如过敏反应,全身性荨麻疹,血管性水肿,其他明显反应)的病史,或有对两种或以上药物、食物过敏者; 2 正在进行化疗或者已诊断为其他肿瘤的患者; 3 HIV,HBV,HCV,或COVID-19感染者; 4 有需要治疗的全身性活动性感染:系统性真菌、细菌、病毒或其它感染等; 5 筛选期间或首次给药前发生原因不明发热>37.2°C; 6 存在对遵从试验要求产生影响的精神疾病史或药物滥用史; 7 受试者筛选期血常规,血生化、病毒学检查、经研究者判断异常有临床意义者; 8 首次细胞注射前(第1周期,第1天)30天内接种过活疫苗; 注:允许首次细胞注射前30天内接受针对季节性流感的注射用灭活病毒疫苗,但是不允许接受鼻内用药的减毒活流感疫苗; 9 有可能干扰试验结果,妨碍受试者全程参与研究的病史或疾病证据,治疗或实验室检查值异常,或研究者认为其他不适合入组的情况; 10 首次细胞回输前2年内发生过需要全身性治疗(例如使用缓解疾病药物、皮质类固醇或免疫抑制剂)的活动性自身性免疫疾病,如系统性红斑狼疮。替代疗法(例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性皮质类固醇等)不视为全身性治疗; 11 妊娠或哺乳期女性; 12 受试者不同意在研究期间及随后的1年内使用有效避孕措施; 13 患有其他任何严重疾病,研究者认为可能影响受试者的治疗、随访或评估,包括任何未被控制的有临床意义的神经、精神疾病、免疫调节性疾病、代谢性疾病及传染病等,四周内接受过非诊断目的的重大手术; 14 严重的心肺功能不全受试者,有高血压且血压无法用药物控制正常,有不稳定冠状动脉疾病(不可控的心律失常,不稳定心绞痛),不可代偿的充血性心衰,入组前6个月内有心肌梗塞。 15 试验前3个月内参与其他临床试验并使用了试验药物或器械者。 

Exclusion criteria:

1. Allergic, persons who had a history of allergy to vaccine or severe reaction, such as Hypersensitivity, systemic urticaria, blood vessel edema, or other obviously reaction, or are allergy to two or more drugs or food; 2. Persons who are under chemotherapy or have conformed cancers; 3. Persons who are infected with HIV, HBV, HCV or COVID-19; 4. Persons who have active infection that need systemic treatment, such as systemic fugus infection, bacterial infection, viral infection or other infection; 5. Body temperature >37.2°C during screening or before first DC injection 6. Prior history of drug abuse or psychological disease that may affect follow the study requirements; 7. In opinions of principal investigator, participant has abnormal results of blood test, blood biochemical test or viral test; 8. Persons who has received a live vaccine within 30 days of the first DC injection. Note: seasonal inactive flu shot within 30 days of first DC injection is allowed, but attenuated in-nose live flu shot is not allowed; 9. In opinions of principal investigator, participants may not be eligible or are not able to comply with the study, who have a prior history of disease, receiving certain kind of treatment, abnormal results, or other concerns; 10. Active autoimmune disease patients such as SLE, who need systemic treatment, such as Systemic corticosteroid therapy or immunosuppressive drugs within two years of first DC injection. Replace therapy is not considered as systemic treatment, such as Thyroid hormones, Insulin, or physiological Corticosteroid therapy for patients with decreased Adrenal Gland or pituitary gland functions; 11. Pregnant or breast-feeding women; 12. Persons refuse to practice birth control within one year during study and follow-up; 13. Persons who have disease, such as uncontrolled neurological or psychological disease, immune dysregulated disease, metabolism disease, infectious disease, or received therapeutic surgery, that investigator concern that may affect finish the study, including DC injection, follow-up or evaluation; 14. Persons have severe defects in heart and lung functions: uncontrolled high blood pressure, unstable coronary artery vessel disease (such as uncontrolled cardiac arrhythmia, or unstable angina pectoris), congestive heart failure, myocardial infarction within 6 months of enrollment; 15. Persons participate other clinical trials and have received study drugs or instruments three months before. 

研究实施时间:

Study execute time:

From2020-04-16To 2022-04-15 

征募观察对象时间:

Recruiting time:

From2020-05-23To 2021-05-22 

干预措施:

Interventions:

组别:

Case series

样本量:

25

Group:

Case series

Sample size:

干预措施:

负载COVID19 s-vax自体DC细胞注射

干预措施代码:

Intervention:

COVID19 s-vax loaded autologous dendritic cell injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

聊城 

Country:

China 

Province:

Shandong 

City:

Liaocheng 

单位(医院):

聊城市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Liaocheng People's Hospital  

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:

CTCAE V5.0

Measure time point of outcome:

Measure method:

CTCAE V5.0

指标中文名:

血清抗COVID-19 S蛋白抗体在受试者的转阳性率

指标类型:

次要指标 

Outcome:

seroconversion rate anti-COVID19 S-protein after DC injection

Type:

Secondary indicator 

测量时间点:

测量方法:

ELISA

Measure time point of outcome:

Measure method:

ELISA

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

外周血

组织:

Sample Name:

Peripheral blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 60 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-randomization

盲法:

N/A

Blinding:

N/A

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):

学术期刊发表,发表日期未定

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

Publish in medical reserach journal. Pulish date has not determined yet.

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:

病例报告表

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

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-06-22
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