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CART细胞治疗晚期ALPP阳性肿瘤的安全性和有效性临床研究
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注册号:

Registration number:

ChiCTR2100053829 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

CART细胞治疗晚期ALPP阳性肿瘤的安全性和有效性临床研究 

Public title:

Clinical study on the safety and effectiveness of CART cells in the treatment of advanced ALPP-positive tumors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CART细胞治疗晚期ALPP阳性肿瘤的安全性和有效性临床研究 

Scientific title:

Clinical study on the safety and effectiveness of CART cells in the treatment of advanced ALPP-positive tumors 

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:

陈耐飞 

研究负责人:

崔久嵬 

Applicant:

Naifei Chen 

Study leader:

Jiuwei Cui 

申请注册联系人电话:

Applicant telephone:

0431-88783172 

研究负责人电话:

Study leader's telephone:

0431-88783172 

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:

chennaifei@163.com 

研究负责人电子邮件:

Study leader's E-mail:

cuijw@jlu.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:

吉林省长春市朝阳区新民大街1号吉林大学第一医院7号楼3楼 

研究负责人通讯地址:

吉林省长春市朝阳区新民大街1号吉林大学第一医院7号楼3楼 

Applicant address:

3rd Floor, Building 7, Jilin University First Hospital, No. 1 Xinmin Street, Chaoyang District, Changchun City, Jilin Province, China 

Study leader's address:

3rd Floor, Building 7, Jilin University First Hospital, No. 1 Xinmin Street, Chaoyang District, Changchun City, Jilin Province, 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:

吉林大学白求恩第一医院 

Applicant's institution:

The First Bethune Hospital of Jilin 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:

210714-01 

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:

吉林大学第一医院干细胞伦理委员会 

Name of the ethic committee:

Stem Cell Ethics Committee of the First Hospital of Jilin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-07-15 

伦理委员会联系人:

牛俊奇 

Contact Name of the ethic committee:

Niu Junqi 

伦理委员会联系地址:

吉林省长春市朝阳区新民大街1号 

Contact Address of the ethic committee:

No. 1 Xinmin Street, Changchun City, Jilin Province, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0413-88782013 

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:

吉林大学白求恩第一医院 

Primary sponsor:

The First Bethune Hospital of Jilin University 

研究实施负责(组长)单位地址:

吉林大学白求恩第一医院 

Primary sponsor's address:

The First Bethune Hospital of Jilin University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

吉林

市(区县):

长春

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

吉林大学白求恩第一医院

具体地址:

吉林省长春市朝阳区新民大街1号

Institution
hospital:

The First Bethune Hospital of Jilin University

Address:

No. 1 Xinmin Street, Changchun City, Jilin Province, China

经费或物资来源:

上海斯丹赛生物技术有限公司 

Source(s) of funding:

Innovative Cellular Therapeutics Co.,Ltd. 

研究疾病:

卵巢癌,黑色素瘤,胰腺癌,胃癌等 

Target disease:

Ovarian cancer, melanoma, pancreatic cancer, gastric cancer, etc. 

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:

研究的目的是评价CAR-T靶向治疗晚期ALPP阳性肿瘤患者的安全性、耐受性、有效性。 

Objectives of Study:

To evaluate the safety, tolerability and effectiveness of CAR-T targeted therapy in patients with advanced ALPP-positive tumors 

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18-65岁之间; 2. 在经合作方认可的实验室的免疫组化(IHC)测定靶点表达阳性; 3. 病理学证实消化道肿瘤; 4. 至少经过一、二线标准治疗无效或复发的患者,对于标准化治疗不耐受或自愿放弃的患者; 5. 按 RECIST1.1或EORTC或PERCIST标准至少具有一个颅外可测量病灶; 6. 预计生存期≥90天; 7. 主要器官功能正常,即符合下列标准: 1) ECOG体能状态评分为0~1或者KPS分数>70; 2) 血常规检查标准符合:HB≥90g/L (14天内未输血),ANC≥ 1.5 x 10^9/L,PLT≥80 x 10^9/L,Alb ≥ 2.8g/dL,serum lipase and amylase < 1.5×ULN(正常值上限); 3) 生化检查需符合以下标准:TBIL≤1.5 x ULN(正常值上限);ALT和AST≤2.5 x ULN;如有肝转移,则ALT和AST≤5xULN;血清Cr≤1xULN,内生肌酐清除率>50 ml/min (Cockcroft-Gault公式); 4) 心脏射血分数>55%; 8. 没有出血性疾病或凝血功能障碍; 9. 对显影剂不产生过敏; 10. 育龄妇女必须在入组前7天内进行妊娠实验(血清或尿液),且结果为阴性,并且愿意在实验期间和末次给予CART后8周采用适当的方法避孕(接受了绝育术或绝经后至少2年的女性可认定为不具有生育能力); 11. 受试者自愿加入本研究,签署知情同意书,依从性好,配合随访。  

Inclusion criteria

1. Aged 18 - 65 years; 2. Target expression >=1 + as determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; 3. Pathological diagnosis is Digestive tract tumors; 4. Patients who are unable or unsuitable for surgery or who have recurrence after surgery; 5. According to RECIST 1.1 version or EORTC or PERCIST of the standard has at least one measles extracranial measurable lesion has not received radiotherapy; 6. Expected survival of >= 90 days; 7. The main organs function properly, that is, meet the following criteria: 1) The ECOG physical status score is 0-2; 2) Blood test should meet the following criteria: HB >= 90g/L (no blood transfusion within 14 days); ANC >= 1.5x10^9/L; PLT >= 80 x 10^9/L; 3) Biochemical tests should meet the following criteria: TBIL <= 1.5 x ULN (upper limit of normal); ALT and AST<=2.5 x ULN; ALT and AST <= 5 x ULN if liver metastases; serum Cr <= 1xULN, endogenous creatinine clearance > 50 ml / min (Cockcroft-Gault formula); 8. There was no hemorrhagic disease or coagulation dysfunction; 9. No allergy to the contrast agent; 10. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment and the result is negative and are willing to use appropriate methods of contraception either during the experiment and 8 weeks after the last dose of CART (subject to sterilization or menopause women who have been at least 2 years old can be considered as having no fertility); 11. Participants voluntarily joined the study, signed informed consent, compliance is good, with follow-up.  

排除标准:

1.既往有其他恶性肿瘤病史; 2.T细胞转导效率<5%或者培养后T细胞扩增小于2倍; 3.研究开始前4周内参加过其他药物临床试验; 4.患有高血压且经单一降压药物无法获得良好控制者(收缩压 > 140 mmHg,舒张压>90 mmHg,具体情况由研究者评判),患有I级以上心肌缺血或心肌梗塞、I级及以上心律失常(包括QT间期≥ 440ms)或心功能不全; 5.长期未愈合的胸部或其他部位的伤口或骨折; 6.具有精神类药物滥用史且无法戒除者或有精神障碍史者; 7.既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的患者; 8.存在不可控制或需要抗生素治疗的真菌、细菌、病毒或其他感染。在咨询医学监查员后,允许存在单纯的尿路感染和无并发症的细菌性咽炎; 9.对于既往使用过化疗的受试者,根据NCI-CTCAE 4.0标准,入组时存在≥2级血液学毒性,或≥3级非血液学毒性; 10.已知存在HIV病史,或乙型肝炎(HBsAg阳性)或丙型肝炎病毒(抗HCV阳性)核酸检测阳性; 11.存在任何留置导管或引流管(如,胆汁引流管或胸膜/腹膜/心包导管)。允许使用专用中心静脉导管; 12.有脑转移的情况; 13.存在CNS病史或疾病,如癫痫发作疾病、脑缺血/出血、痴呆、小脑疾病,或任何涉及CNS的自身免疫性疾病; 14.存在重大免疫缺陷; 15.对本研究中的主要治疗药物(包括预处理期间使用的氟达拉滨、环磷酰胺、美司钠以及防治CRS的托珠单抗及抗感染药物等)具有重度超敏反应病史; 16.入组前6个月内存在深静脉血栓或肺栓塞病史; 17. 过去2年内存在导致末端器官损伤或需要全身免疫抑制/全身疾病调节药物的自身免疫性疾病(如,克罗恩氏病、类风湿性关节炎、系统性红斑狼疮)病史; 18.有任何可能对研究治疗的安全性或疗效评估产生干扰的疾病。 

Exclusion criteria:

1.Previous history of other malignant tumors;2.T cell transduction efficiency <5% or T cell expansion less than 2 times after culture; 3. Participated in other drug clinical trials within 4 weeks before the start of the study; 4. Patients with hypertension who are not well controlled by a single antihypertensive medication (systolic > 140 mmHg, diastolic> 90 mmHg), patients with grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias Including QT interval >= 440ms) or complete cardiac function; 5. Long-term unhealed chest or other parts of the wound or fracture; 6. Those with a history of abuse of psychotropic substances who can not be abstinent or who have mental disorders; 7. Past and current patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired pulmonary function; 8. There are fungi, bacteria, viruses, or other infections that can not be controlled or require antimicrobial treatment. If there is a response to active therapy, a simple urinary tract infection and no complication of bacterial pharyngitis are allowed after consultation with the medical examiner; 9. For subjects with previously used chemotherapy, >= 2 hematologic toxicity or >= 3 non-hematologic toxicity at enrollment according to NCI-CTCAE 4.0 criteria; 10. Known history of HIV or Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) infection is known; 11. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural/peritoneal/pericardial catheters). Allow use of a dedicated central venous catheter; 12. Brain metastases; 13. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. There is a significant immunodeficiency; 15. Have a history of severe hypersensitivity reactions to the major therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab and anti-infectives against CRS during pretreatment 16. There was a history of deep venous thrombosis or pulmonary embolism within the first 6 months of enrollment; 17. A history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause damage to the terminal organ or that require systemic immunosuppression / systemic disease modulation over the past two years; 18. With hemorrhagic disease or coagulation dysfunction.  

研究实施时间:

Study execute time:

From2021-08-23To 2026-07-15 

征募观察对象时间:

Recruiting time:

From2021-11-15To 2026-07-15 

干预措施:

Interventions:

组别:

试验组

样本量:

12

Group:

experimental group

Sample size:

干预措施:

CAR-T 细胞

干预措施代码:

Intervention:

CAR-T Cell

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学白求恩第一医院 

单位级别:

三甲 

Institution
hospital:

The First Bethune Hospital of Jilin University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

PET/CT

指标类型:

主要指标 

Outcome:

PET/CT

Type:

Primary indicator 

测量时间点:

筛选期,M1,M3,M6,M9,M12等按照方案中进行

测量方法:

PET/CT

Measure time point of outcome:

Measure method:

PET/CT

指标中文名:

RECIST1.1

指标类型:

次要指标 

Outcome:

RECIST1.1

Type:

Secondary indicator 

测量时间点:

客观缓解率评估

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:

正在进行

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):

未使用

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

Not used

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

上海斯丹赛生物技术有限公司官网,www.ictbio.com

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

www.ictbio.com

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:

CRF

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2021-11-30
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