Spots Global Cancer Trial Database for A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
Official Title: Multi-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-antigen Autologous Immune Cell Injection (MASCT-I) in Patients With Advanced Solid Tumor, and to Preliminarily Evaluate the Anti-tumor Efficacy of MASCT-I Alone, in Combination With Chemical Drugs, and in Combination With PD1 Antibody
Study ID: NCT03034304
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with advanced solid tumors, either alone or in combination with chemical drugs or in combination with PD1 antibody.
Detailed Description: The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is optimized continuously and has been upgraded from the first-generation MASCT technology to MASCT-I. MASCT-I is a technology which add PD1 antibody in vitro cell culture process of MASCT cell culture to block PD1 receptor on immunocytes, release the brake on immunocytes' reinfusion and interaction with tumor cells for enhancing the efficacy of immunocytes' killing tumor cells. At present, the development and validation of manufacturing process has been completed, and it is urgently needed to conduct the validation of clinical effect. This is a Multi-center, phase I clinical study to evaluate the safety and tolerability of multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid tumor, and to preliminarily evaluate the anti-tumor efficacy of MASCT-I alone, in combination with chemical drugs, and in combination with PD1 antibody. About 193 cases of adult patients with advanced solid tumors will be recruited.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
Shanghai Tenth People's Hospital, Shanghai, Shanghai, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Tumor Hospita, Hangzhou, Zhejiang, China
Contact Details
Name: Ruihua Xu, Doctor
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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