[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509268":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":143,"collaborators":145,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":32,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":32,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"CARsgen Therapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"anti-claudin18.2 chimeric antigen receptor T-cell therapy","EXPERIMENTAL","Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041",[13],"Drug: CT041 autologous CAR T-cell injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CT041 autologous CAR T-cell injection","Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion",[9],[21],"Single Group Assignment",[23],{"name":24,"affiliation":25,"role":26},"Xianjun Yu, Ph.D","Fudan University","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Lifeng Zhang","CONTACT","86-21-54489928",null,"lifengzhang@carsgen.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Ning Wang","86-21-54489926","ningwang@carsgen.com",[39,56,69,82,95,109,122,130],{"facility":40,"status":41,"city":42,"state":43,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":30,"phone":32,"phoneExt":32,"email":55},"Lin Shen, PhD","doctorshenlin@sina.cn",{"facility":57,"status":41,"city":58,"state":59,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":47,"coordinates":61},[62,63],113.64861,34.75778,{"lat":63,"lon":62},[66],{"name":67,"role":30,"phone":32,"phoneExt":32,"email":68},"Xiaobing Chen, Ph.D","zlyychenxb0807@zzu.edu.cn",{"facility":70,"status":41,"city":71,"state":72,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology","Wuhan","Hubei",{"type":47,"coordinates":74},[75,76],114.26667,30.58333,{"lat":76,"lon":75},[79],{"name":80,"role":30,"phone":32,"phoneExt":32,"email":81},"Heshui Wu, Ph.D","heshuiwu@hust.edc.cn",{"facility":83,"status":41,"city":84,"state":85,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hunan Provincial People's Hospital","Changsha","Hunan",{"type":47,"coordinates":87},[88,89],112.97087,28.19874,{"lat":89,"lon":88},[92],{"name":93,"role":30,"phone":32,"phoneExt":32,"email":94},"Wei Cheng, Ph.D","13974866177@163.com",{"facility":96,"status":41,"city":97,"state":98,"zip":99,"country":44,"countryCode":45,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine","Shanghai","Shanghai Municipality","200025",{"type":47,"coordinates":101},[102,103],121.45806,31.22222,{"lat":103,"lon":102},[106],{"name":107,"role":30,"phone":32,"phoneExt":32,"email":108},"Jun Zhang, Ph.D","junzhang@188.com",{"facility":110,"status":41,"city":97,"state":98,"zip":111,"country":44,"countryCode":45,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Fudan University Shanghai Cancer Hospital","201321",{"type":47,"coordinates":113},[102,103],{"lat":103,"lon":102},[116,119],{"name":24,"role":30,"phone":117,"phoneExt":32,"email":118},"02164175590","yuxianjun@fudanpci.org",{"name":120,"role":30,"phone":117,"phoneExt":32,"email":121},"Jian Zhang, Ph.D","Syner2000@163.com",{"facility":123,"status":41,"city":124,"state":125,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":32,"geoPoint":32,"contacts":126},"The First Affiliated Hospital of Xi'an Jiaotong University","Xian","Shanxi",[127],{"name":128,"role":30,"phone":32,"phoneExt":32,"email":129},"Zheng Wu","woozheng@xjtu.edu.cn",{"facility":131,"status":41,"city":132,"state":133,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang",{"type":47,"coordinates":135},[136,137],120.16142,30.29365,{"lat":137,"lon":136},[140],{"name":141,"role":30,"phone":32,"phoneExt":32,"email":142},"Yiping Mou, Ph.D","yipingmou@126.com",{"type":144,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[146],{"name":25,"class":147},"OTHER","100509268","phase-1-a-study-to-evaluate-the-efficacy-and-safety-of-ct041-after-adjuvant-chemotherapy-for-pancreatic-cancer-100509268",false,"NCT05911217","A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer","An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer","Inclusion Criteria:\n\n1. Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures;\n2. Aged 18 to 79 years;\n3. Histologically confirmed pancreatic ductal adenocarcinoma;\n4. Macroscopic complete tumor removal (R0 or R1 resection);\n5. Postoperative pathological stage (pTNM): T1-3, N0-2, M0;\n6. Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;\n7. Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;\n8. Abnormal CA19-9 level;\n9. With sufficient venous access for leukapheresis collection;\n10. ECOG performance status score 0-1;\n11. Adequate organ function;\n12. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;\n\nExclusion Criteria:\n\n1. Prior neoadjuvant therapy for pancreatic cancer;\n2. Subjects with borderline resectable pancreatic cancer;\n3. Present or past history of metastatic or locally recurrent pancreatic cancer;\n4. Evidence of malignant ascites;\n5. Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.\n6. Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;\n7. Pregnant or lactating women;\n8. Positive serology for HIV, Treponema pallidum or HCV;\n9. Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;\n10. Clinically significant thyroid dysfunction;\n11. Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;\n12. Subjects who may be at high risk for potential digestive tract bleeding or perforation;\n13. Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;\n14. Subjects who have a history of organ transplantation or are awaiting organ transplantation;\n15. Subjects who require anticoagulant therapy;\n16. Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;\n17. Subjects who have experienced major surgery or have significant trauma within 4 weeks before apheresis, or who are expected to undergo major surgery during the study period;\n18. Previously received any gene-modified cell therapies (including CAR T, TCR T);\n19. Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;\n20. Subjects with oxygen saturation ≤ 95%;\n21. Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;\n22. Subjects who have other uncured malignant tumors in the past 3 years or at the same time, except those with very low degree of malignancy such as cervical cancer in situ and basal cell carcinoma of skin;\n23. Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;\n24. Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.","ALL","18 Years","79 Years",{"count":159,"type":160},20,"ESTIMATED","INTERVENTIONAL",[163],"PHASE1","An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.",[166],"Pancreatic Cancer",[168,166,169,170,171],"Adjuvant therapy","Claudin18.2","CLDN18.2","CAR T cell","2024-05-24",{"date":174,"type":175},"2024-05-28","ACTUAL",{"date":177,"type":175},"2023-07-11",{"date":179,"type":160},"2026-12-31",{"name":5,"class":6},8]