Trial Title:
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
NCT ID:
NCT05709093
Condition:
Myelodysplastic Syndromes(MDS)
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lemzoparlimab+Azacitidine (AZA)
Description:
1. Lemzoparlimab is administered by intravenous (IV) infusion once a week at a dose of
30 mg/kg in 28-day treatment cycles
2. Azacitidine (AZA): AZA is administered by subcutaneous injection once a day at a
dose of 75 mg/m2 on D1 to D7 of each treatment cycle in 28-day treatment cycles.
Arm group label:
Lemzoparlimab in combination with AZA
Intervention type:
Drug
Intervention name:
Azacitidine (AZA)
Description:
AZA is administered by subcutaneous injection once a day at a dose of 75 mg/m2 on D1 to
D7 of each treatment cycle in 28-day treatment cycles.
Arm group label:
AZA monotherapy
Summary:
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate
the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA
monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and
high-risk MDS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female, ≥ 18 years of age at the time of signing the ICF.
- Subjects with intermediate- and high-risk MDS who are confirmed by bone marrow
aspiration or pathological biopsy according to the diagnostic criteria of World
Health Organization (WHO) 2016 or who are eligible for blasts in bone marrow and
peripheral blood < 20% and have a score > 3.5 according to the revised International
Prognostic Scoring System (IPSS-R).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Subjects without any prior anti-tumor therapy for MDS, including demethylated drugs
(eg, AZA, decitabine), chemotherapy, targeted therapy, or HSCT. The blood
transfusion or use of hematopoietic growth factors and supplementation of
hematopoietic raw materials such as folic acid, vitamin B12 are permitted. For
patients who ever took lenalidomide, thalidomide, antithymocyte globulin (ATG), or
ciclosporin before study entry, there should be a washout period of at least 28 days
prior to the first dose.
- Subjects who are eligible for HSCT and have no pre-scheduled HSCT at screening, or
subjects who are ineligible for HSCT and have no scheduled HSCT at screening
- Expected survival ≥ 12 weeks
- Subjects with adequate organ function and laboratory tests meet the following
requirements
- Female subjects of childbearing potential or male subjects whose partner is a woman
of childbearing potential are required to use effective contraception throughout the
treatment period and until 6 months after the treatment period.
- Subjects must be willing to provide available diagnostic evidence or undergo bone
marrow aspiration and biopsy before study treatment, and must be willing to undergo
bone marrow aspiration and biopsy after receiving study treatment.
- Subjects must give informed consent before starting the study and sign written ICF
voluntarily by themselves (or their legal representatives). Subjects or their legal
representatives should be able to communicate well with investigators and agree to
adhere with the study protocol and complete the study
Exclusion Criteria:
- Patients who have transformed from MDS to AML, or have been diagnosed with
treatment-related MDS (t-MDS), or patients with myeloproliferative neoplasia (MPN)
or myelodysplastic syndrome/myeloproliferative disorder (MDS/MPN) that meet WHO 2016
criteria
- Previously received any anti-CD47 antibody or SIRPα antibody or the drugs targeting
the same target
- Subjects have received or plan to receive the allogeneic stem cell transplantation
or organ transplantation during the study
- History of chronic hemolytic anemia due to other diseases or clinically significant
positive hemolysis-related test at screening (except positive hemolysis test due to
MDS)
- Concurrent participation in another interventional clinical study, unless it is an
observational (non-interventional) clinical study or during the follow-up period of
an interventional study
- Subjects plan to receive other anti-tumor therapies, including but not limited to
chemotherapy, biotherapy and immunotherapy, while participating in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital Of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233099
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanli Yang, Doctor
Email:
Yangyanli0702@126.com
Investigator:
Last name:
Yanli Yang, Doctor
Email:
Principal Investigator
Facility:
Name:
THE First Affiliated Hospital Of Anhui Medical University
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ruixiang Xia, Doctor
Email:
xrx2041@163.com
Investigator:
Last name:
Ruixiang Xia, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affilated Hospital Of USTC Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Baolin Tang, Doctor
Email:
zwcrystalbl@163.com
Investigator:
Last name:
Baolin Tang, Doctor
Email:
Principal Investigator
Facility:
Name:
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100037
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Li, Doctor
Email:
lijian@pumch.cn
Investigator:
Last name:
Jian Li, Doctor
Email:
Principal Investigator
Facility:
Name:
Beijing Gaobo Boren Hospital Co., Ltd
Address:
City:
Beijing
Zip:
100070
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tong Wu, Doctor
Email:
wut@gobroadhealthcare.com
Investigator:
Last name:
Tong Wu, Doctor
Email:
Principal Investigator
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongmei Jing, Doctor
Email:
hongmei_jing@163.com
Investigator:
Last name:
Hongmei Jing, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of PLA Army Military Medical University
Address:
City:
Chongqing
Zip:
400037
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shuangnian Xu, Doctor
Email:
xushuangnian@tmmu.edu.cn
Investigator:
Last name:
Shuangnian Xu, Doctor
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Army Medical University
Address:
City:
Chongqing
Zip:
400037
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xi Zhang, Doctor
Email:
zhangxxi@sina.com
Investigator:
Last name:
Xi Zhang, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Wang, Doctor
Email:
Liwangls@yahoo.com
Investigator:
Last name:
Li Wang, Doctor
Email:
Sub-Investigator
Facility:
Name:
The Affiliated Zhongshan Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
61004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Quanyi Lu, Doctor
Email:
luquanyi@xmu.edu.cn
Investigator:
Last name:
Quanyi Lu, Doctor
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Danian Nie, Doctor
Email:
niedanian@hotmail.com
Investigator:
Last name:
Danian Nie, Doctor
Email:
Principal Investigator
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510260
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanjie He, Doctor
Email:
hyjgzh2006@163.com
Investigator:
Last name:
Yanjie He, Doctor
Email:
Principal Investigator
Facility:
Name:
Southern Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
516006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qifa Liu, Doctor
Email:
berrydai2003@aliyun.com
Investigator:
Last name:
Qifa Liu, Doctor
Email:
Principal Investigator
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
519041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianyu Weng, Doctor
Email:
wengjianyu1969@163.com
Investigator:
Last name:
Jianyu Weng, Doctor
Email:
Principal Investigator
Facility:
Name:
Shenzhen Second People's Hospital
Address:
City:
Shenzhen
Zip:
518025
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xin Du, Doctor
Email:
duxingz@medmail.com.cn
Investigator:
Last name:
Xin Du, Doctor
Email:
Principal Investigator
Facility:
Name:
First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ling Qin, Doctor
Email:
zzqq777@126.com
Investigator:
Last name:
Ling Qin, Doctor
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hu Zhou, Doctor
Email:
papertigerhu@163.com
Investigator:
Last name:
Hu Zhou, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhongxing Jiang, Doctor
Email:
jiangzx@zzu.edu.cn
Investigator:
Last name:
Zhongxing Jiang, Doctor
Email:
Principal Investigator
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
463599
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zunming Zhu, Doctor
Email:
zhuzm1964@163.com
Investigator:
Last name:
Zunming Zhu, Doctor
Email:
Principal Investigator
Facility:
Name:
Harbin First Hospital
Address:
City:
Harbin
Zip:
150010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tiejun Gong, Doctor
Email:
arc@sina.com
Investigator:
Last name:
Tiejun Gong, Doctor
Email:
Principal Investigator
Facility:
Name:
Tongji Medical College of HUST
Address:
City:
Wuhan
Zip:
30030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fankai Meng, Doctor
Email:
doctormeng@163.com
Investigator:
Last name:
Fankai Meng, Doctor
Email:
Principal Investigator
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
zhichao Chen, Doctor
Investigator:
Last name:
Zhichao Chen, Doctor
Email:
Principal Investigator
Facility:
Name:
Changsha Third Hospital
Address:
City:
Changsha
Zip:
410035
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
zengmei Sheng, Doctor
Email:
shengzengmei@163.com
Investigator:
Last name:
zengmei Sheng, Doctor
Email:
Principal Investigator
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Chang chun
Zip:
130061
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Sujun Gao, Doctor
Email:
sujung1963@163.com
Investigator:
Last name:
Sujun Gao, Doctor
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hosptial Of XuZhou Medical University
Address:
City:
Xuzhou
Zip:
221004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feng Zhu, Doctor
Email:
lizhenyumd@163.com
Investigator:
Last name:
Feng Zhu, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li, Doctor
Email:
yx021021@sina.com
Investigator:
Last name:
Fei Li, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaojing Yan, Doctor
Email:
yanxiaojing_pp@hotmail.com
Investigator:
Last name:
Xiaojing Yan, Doctor
Email:
Principal Investigator
Facility:
Name:
Shaanxi Provincial People's Hospital
Address:
City:
Xian
Zip:
710068
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yi Wang, Doctor
Email:
13571936193@163.com
Investigator:
Last name:
Yi Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aili He, Doctor
Email:
heaili@xjtu.edu.cn
Investigator:
Last name:
Aili He, Doctor
Email:
Principal Investigator
Facility:
Name:
Cheeloo College of Medicine, Shandong University
Address:
City:
Jinan
Zip:
250063
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ming Hou, Doctor
Email:
houmingHaoli611@medmail163.com
Investigator:
Last name:
Ming Hou, Doctor
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Medical College Qingdao University
Address:
City:
Qingdao
Zip:
266003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Wang, Doctor
Email:
18661807392@163.com
Investigator:
Last name:
Wei Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Shandong First Medical University
Address:
City:
Tai'an
Zip:
271099
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhirong Zhang, Doctor
Email:
tyfyzzr@163.com
Investigator:
Last name:
Zhirong Zhang, Doctor
Email:
Principal Investigator
Facility:
Name:
Taian City Central Hospital
Address:
City:
Taian
Zip:
271099
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qingliang Teng, Doctor
Email:
tatql@163.com
Investigator:
Last name:
Qingliang Teng, Doctor
Email:
Principal Investigator
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
30032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liangming Ma, Doctor
Email:
Maliangming620928@163.com
Investigator:
Last name:
Liangming Ma, Doctor
Email:
Principal Investigator
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Sujiang Zhang, Doctor
Email:
zbruce.zhang@hotmail.com
Investigator:
Last name:
Sujiang Zhang, Doctor
Email:
Principal Investigator
Facility:
Name:
Tongji Hospital of Tongji University
Address:
City:
Shanghai
Zip:
200065
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiuqin Wang, Doctor
Email:
1419832912@qq.com
Investigator:
Last name:
Xiuqin Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hua Zhong, Doctor
Email:
zhh_lj@163.com
Investigator:
Last name:
Hua Zhong, Doctor
Email:
Principal Investigator
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Zip:
201306
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunkang Chang, Doctor
Email:
changchunkang@sina.com
Investigator:
Last name:
Chunkang Chang, Doctor
Email:
Principal Investigator
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Wu, Doctor
Email:
wuyulily@hotmail.com
Investigator:
Last name:
Yu Wu, Doctor
Email:
Principal Investigator
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuelei Ma, Doctor
Email:
mxlmax@163.com
Investigator:
Last name:
Xuelei Ma, Doctor
Email:
Principal Investigator
Facility:
Name:
Affiliated Hospital of North Sichuan Medical College
Address:
City:
Nanchong
Zip:
637000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jin Wei, Doctor
Email:
1497058875@qq.com
Investigator:
Last name:
Jin Wei, Doctor
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rong Fu, Doctor
Email:
furong3001@126.com
Investigator:
Last name:
Rong Fu, Doctor
Email:
Principal Investigator
Facility:
Name:
Hematology Hospital of Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijian Xiao, Doctor
Email:
zjxiao@ihcams.ac.cn
Investigator:
Last name:
Zhijian Xiao, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University Medical College
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongyan Tong, Doctor
Email:
hongyantong@aliyun.com
Investigator:
Last name:
Hongyan Tong, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital Of WenZhou Medical College
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Songfu Jiang, Doctor
Email:
jiangsongfu@189.cn
Investigator:
Last name:
Songfu Jiang, Doctor
Email:
Principal Investigator
Start date:
March 30, 2023
Completion date:
March 31, 2027
Lead sponsor:
Agency:
TJ Biopharma Co., Ltd.
Agency class:
Industry
Source:
TJ Biopharma Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709093
