Spots Global Cancer Trial Database for A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)
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Trial Identification
Brief Title: A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)
Official Title: Phase 1/2 Clinical Study on Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Study ID: NCT05066646
Conditions
Interventions
Study Description
Brief Summary: This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of CT103A in subjects with relapsed and refractory MM.
Detailed Description: Leukapheresis procedure will be performed to manufacture CT103A chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT103A at 1.0 x 10\^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
The Affiliated Hospital of Nanjing University Medical School, Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Beijing Boren Hospital, Beijing, , China
Peking University First Hospital, Beijing, , China
Xinqiao Hospital, Army Medical University, Chongqing, , China
Fudan University Zhongshan Hospital, Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, , China
Contact Details
Name: Lugui Qiu, MD, PhD
Affiliation: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Role: PRINCIPAL_INVESTIGATOR
Name: Chunrui Li, MD, PhD
Affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Role: PRINCIPAL_INVESTIGATOR
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