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)

April 11, 2024 updated by: TJ Biopharma Co., Ltd.

A Randomized, Controlled, Open-label, Multicenter 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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

552

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • An Hui
      • Bengbu, An Hui, China, 233099
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Principal Investigator:
          • Yanli Yang, Doctor
      • Hefei, An Hui, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Ruixiang Xia, Doctor
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • The First Affilated Hospital Of USTC Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Baolin Tang, Doctor
    • Bei Jing
      • Beijing, Bei Jing, China, 100037
        • Not yet recruiting
        • Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Jian Li, Doctor
      • Beijing, Bei Jing, China, 100070
        • Not yet recruiting
        • Beijing Gaobo Boren Hospital Co., Ltd
        • Contact:
        • Principal Investigator:
          • Tong Wu, Doctor
      • Beijing, Bei Jing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
        • Principal Investigator:
          • Hongmei Jing, Doctor
    • Chong Qing
      • Chongqing, Chong Qing, China, 400037
        • Not yet recruiting
        • The First Affiliated Hospital of PLA Army Military Medical University
        • Contact:
        • Principal Investigator:
          • Shuangnian Xu, Doctor
      • Chongqing, Chong Qing, China, 400037
        • Not yet recruiting
        • The Second Affiliated Hospital of Army Medical University
        • Contact:
        • Principal Investigator:
          • Xi Zhang, Doctor
      • Chongqing, Chong Qing, China, 400042
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Sub-Investigator:
          • Li Wang, Doctor
    • Fu Jian
      • Xiamen, Fu Jian, China, 61004
        • Not yet recruiting
        • The Affiliated Zhongshan Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Quanyi Lu, Doctor
    • Guang Dong
      • Guangzhou, Guang Dong, China, 510120
        • Not yet recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Danian Nie, Doctor
      • Guangzhou, Guang Dong, China, 510260
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Yanjie He, Doctor
      • Guangzhou, Guang Dong, China, 516006
        • Not yet recruiting
        • Southern Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Qifa Liu, Doctor
      • Guangzhou, Guang Dong, China, 519041
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Jianyu Weng, Doctor
      • Shenzhen, Guang Dong, China, 518025
        • Not yet recruiting
        • Shenzhen Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Xin Du, Doctor
    • He Nan
      • Luoyang, He Nan, China, 450052
        • Not yet recruiting
        • First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Ling Qin, Doctor
      • Zhengzhou, He Nan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hu Zhou, Doctor
      • Zhengzhou, He Nan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Zhongxing Jiang, Doctor
      • Zhengzhou, He Nan, China, 463599
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Zunming Zhu, Doctor
    • Hei Long Jiang
      • Harbin, Hei Long Jiang, China, 150010
        • Not yet recruiting
        • Harbin First Hospital
        • Contact:
        • Principal Investigator:
          • Tiejun Gong, Doctor
    • Hu Bei
      • Wuhan, Hu Bei, China, 30030
        • Not yet recruiting
        • Tongji Medical College of HUST
        • Contact:
        • Principal Investigator:
          • Fankai Meng, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • zhichao Chen, Doctor
        • Principal Investigator:
          • Zhichao Chen, Doctor
    • Hunan
      • Changsha, Hunan, China, 410035
        • Not yet recruiting
        • Changsha Third Hospital
        • Contact:
        • Principal Investigator:
          • zengmei Sheng, Doctor
    • Ji Lin
      • Chang chun, Ji Lin, China, 130061
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Sujun Gao, Doctor
    • Jiang Su
      • Xuzhou, Jiang Su, China, 221004
        • Not yet recruiting
        • The Affiliated Hosptial Of XuZhou Medical University
        • Contact:
        • Principal Investigator:
          • Feng Zhu, Doctor
    • Jiang XI
      • Nanchang, Jiang XI, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
        • Principal Investigator:
          • Fei Li, Doctor
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Xiaojing Yan, Doctor
    • Shaan XI
      • Xian, Shaan XI, China, 710068
        • Not yet recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Yi Wang, Doctor
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
        • Contact:
        • Principal Investigator:
          • Aili He, Doctor
    • Shan Dong
      • Jinan, Shan Dong, China, 250063
        • Not yet recruiting
        • Cheeloo College of Medicine, Shandong University
        • Contact:
        • Principal Investigator:
          • Ming Hou, Doctor
      • Qingdao, Shan Dong, China, 266003
        • Not yet recruiting
        • The Affiliated Hospital of Medical College Qingdao University
        • Principal Investigator:
          • Wei Wang, Doctor
        • Contact:
      • Tai'an, Shan Dong, China, 271099
        • Not yet recruiting
        • The Second Affiliated Hospital of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Zhirong Zhang, Doctor
      • Taian, Shan Dong, China, 271099
        • Not yet recruiting
        • Taian City Central Hospital
        • Contact:
        • Principal Investigator:
          • Qingliang Teng, Doctor
    • Shan XI
      • Taiyuan, Shan XI, China, 30032
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
        • Principal Investigator:
          • Liangming Ma, Doctor
    • Shang Hai
      • Shanghai, Shang Hai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
        • Principal Investigator:
          • Sujiang Zhang, Doctor
      • Shanghai, Shang Hai, China, 200065
        • Not yet recruiting
        • Tongji Hospital of Tongji University
        • Contact:
        • Principal Investigator:
          • Xiuqin Wang, Doctor
      • Shanghai, Shang Hai, China, 200120
        • Not yet recruiting
        • Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
        • Contact:
        • Principal Investigator:
          • Hua Zhong, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 201306
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • Chunkang Chang, Doctor
    • Si Chuan
      • Chengdu, Si Chuan, China, 610044
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Principal Investigator:
          • Xuelei Ma, Doctor
      • Nanchong, Si Chuan, China, 637000
        • Not yet recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
        • Principal Investigator:
          • Jin Wei, Doctor
    • Tian Jin
      • Tianjin, Tian Jin, China, 300052
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Rong Fu, Doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Hematology Hospital of Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Zhijian Xiao, Doctor
    • Zhe Jiang
      • Hangzhou, Zhe Jiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University Medical College
        • Contact:
        • Principal Investigator:
          • Hongyan Tong, Doctor
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325015
        • Not yet recruiting
        • The First Affiliated Hospital Of WenZhou Medical College
        • Contact:
        • Principal Investigator:
          • Songfu Jiang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lemzoparlimab in combination with AZA
Drug: Lemzoparlimab+Azacitidine (AZA)
  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.
Active Comparator: AZA monotherapy
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival Overall Survival(OS)
Time Frame: From date of randomization until the date of first documented progression or date from any cause,whichever came first, assessed up to 50 months.
From date of randomization until the date of first documented progression or date from any cause,whichever came first, assessed up to 50 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TJ Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ011133MDS301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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