Actively Recruiting
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Led by Nanjing IASO Biotechnology Co., Ltd. · Updated on 2025-07-20
240
Participants Needed
28
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years (inclusive)
- Diagnosed with multiple myeloma and received 1-2 prior lines of therapy including proteasome inhibitors and immunomodulatory agents
- Documented disease progression during or within 12 months after the most recent anti-myeloma therapy
- Lenalidomide-refractory during prior therapy
- ECOG performance status score of 0 or 1
- Adequate organ function meeting specified laboratory criteria including blood counts, liver and kidney function, coagulation, oxygen saturation, and heart function
- Agreement to use effective contraception after informed consent
- Signed informed consent form before screening procedures
You will not qualify if you...
- Use of long-term immune-suppressive agents within 14 days prior to enrollment (some steroid forms allowed)
- Autologous hematopoietic stem cell transplant within 12 weeks prior to randomization or previous allogeneic transplant
- Recent anti-tumor treatments within specified time frames, including immunomodulators, plasma exchange, radiotherapy (except local bone lesions), chemotherapy, proteasome inhibitors, monoclonal antibodies, or investigational drugs
- Significant cardiac disorders
- Unstable systemic diseases requiring medication
- History of allergic reaction or intolerance to study drugs or excipients
- Malignancies other than multiple myeloma within 5 years, except certain treated cancers
- Central nervous system involvement by multiple myeloma
- Concurrent plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary amyloidosis
- Certain forms or sizes of extramedullary multiple myeloma lesions
- Major surgery within 2 weeks before randomization or planned within 2 weeks after treatment (except local anesthesia)
- Uncontrolled infections
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- Pregnant or breastfeeding women
- History of central nervous system disorder within 6 months prior to consent
- Ongoing non-hematological toxicities from prior treatment except specific exceptions
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Actively Recruiting
2
Beijing GoBoard Boren Hospital
Beijing, China
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3
Fu Xing Hospital, Capital Medical University
Beijing, China
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, China
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5
Peking University First Hospital
Beijing, China
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6
Peking University Third Hospital
Beijing, China
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7
People's Hospital of Peking University
Beijing, China
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8
The first hospital of Jilin University
Changchun, China
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9
West China School of Medicine, West China Hospital of Sichuan University
Chengdu, China
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10
Xinqiao Hospital of AMU
Chongqing, China
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11
Nanfang Hospital, Southern Medical University
Guangzhou, China
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12
Sun Yat-sen University Cancer Centre
Guangzhou, China
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13
Zhujiang Hospital of Southern Medical University Guangdong
Guangzhou, China
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14
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
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15
The Second Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, China
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16
Qilu Hospital of Shangdong University
Jinan, China
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17
The First Affiliated Hospital of Nanchang University
Nanchang, China
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18
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
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19
Jiangsu Province Hospital
Nanjing, China
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20
The Affiliated People's Hospital of Ningbo University
Ningbo, China
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21
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
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22
The First Affiliated Hospital of Soochow University
Suzhou, China
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23
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjing, China
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24
Tianjin Medical University General Hospital
Tianjing, China
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25
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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26
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
27
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
28
Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yue Wan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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