Spots Global Cancer Trial Database for Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
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Trial Identification
Brief Title: Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
Official Title: Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study
Study ID: NCT06093841
Study Description
Brief Summary: The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
Detailed Description: This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sun Yat-sen University Cancer Hospital, Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Shandong Cancer Hospital, Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,, Shanghai, Shanghai, China
Institute of Hematology&Hospital of Blood Disease CAMS, Tianjin, Tianjin, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Beijing Tongren Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jiangsu Provincial People's Hospital, Nanjing, , China
Contact Details
Name: Weili Zhao, PhD
Affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Role: PRINCIPAL_INVESTIGATOR
Name: Depei Wu, PhD
Affiliation: The First Affiliated Hospital of Soochow University
Role: PRINCIPAL_INVESTIGATOR
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