Spots Global Cancer Trial Database for Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
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Trial Identification
Brief Title: Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
Official Title: An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
Study ID: NCT04581473
Study Description
Brief Summary: An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer
Detailed Description: This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Peking University Shenzhen Hospital, Shenzhen, Guangzhou, China
Harbin medical university Affiliated Cancer Hospital, Harbin, Heilongjia, China
Henan Tumor Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanghai Zhongshan Hospital, Shanghai, Shanghai, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hanzhou, Zhejiang, China
Contact Details
Name: Lin Shen, Professor
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Xianjun Yu, Professor
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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