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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Sponsor: Nanjing IASO Biotechnology Co., Ltd.
Summary
This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.
Official title: A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-03-27
Completion Date
2030-12
Last Updated
2025-07-20
Healthy Volunteers
No
Conditions
Interventions
Equecabtagene Autoleucel Injection
dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.
Daratumumab
dosage form: Injection dose level:16mg/kg frequency: 28days/cycle for DPd regimen * Cycle1-2:D1, D8, D15, D22; * Cycle3-6:D1, D15; * above Cycle7:D1
Pomalidomide
dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.
Bortezomib
dosage form: subcutaneous injection. dose level: 1.3mg/m2. frequency: 21days/cycle for PVd regimen cycle 1-8: D1,D4, D8, D11; above cycle 9: D1, D8.
Dexamethasone
dosage form: oral or intravenus injection. dose level:20mg/d. frequency: for DPd: every cycle, D1, D2, D8, D9, D15, D16, D22, D23; for PVd: Cycle1-8:D1, D2, D4, D5, D8, D9, D11, D12; above Cycle 9: D1, D2, D8, D9.
Locations (28)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Beijing GoBoard Boren Hospital
Beijing, China
Fu Xing Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
People's Hospital of Peking University
Beijing, China
The first hospital of Jilin University
Changchun, China
West China School of Medicine, West China Hospital of Sichuan University
Chengdu, China
Xinqiao Hospital of AMU
Chongqing, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Sun Yat-sen University Cancer Centre
Guangzhou, China
Zhujiang Hospital of Southern Medical University Guangdong
Guangzhou, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
The Second Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, China
Qilu Hospital of Shangdong University
Jinan, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
The Affiliated People's Hospital of Ningbo University
Ningbo, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjing, China
Tianjin Medical University General Hospital
Tianjing, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University
Zhengzhou, China