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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

Interventions

CT103A

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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