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)

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: Terminated
• Conditions: Myelodysplastic Syndromes(MDS)
• Intervention / Treatment: Drug: Lemzoparlimab+Azacitidine (AZA); Drug: Azacitidine (AZA)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • An Hui
    • Bengbu, An Hui, China, 233099
      • The First Affiliated Hospital Of Bengbu Medical College
    • Hefei, An Hui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affilated Hospital Of USTC Anhui Provincial Hospital
  • Bei Jing
    • Beijing, Bei Jing, China, 100037
      • Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Beijing, Bei Jing, China, 100070
      • Beijing Gaobo Boren Hospital Co., Ltd
    • Beijing, Bei Jing, China, 100191
      • Peking University Third Hospital
  • Chong Qing
    • Chongqing, Chong Qing, China, 400037
      • The First Affiliated Hospital of PLA Army Military Medical University
    • Chongqing, Chong Qing, China, 400037
      • The Second Affiliated Hospital of Army Medical University
    • Chongqing, Chong Qing, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
  • Fu Jian
    • Xiamen, Fu Jian, China, 61004
      • The Affiliated Zhongshan Hospital of Xiamen University
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guang Dong, China, 510260
      • ZhuJiang Hospital of Southern Medical University
    • Guangzhou, Guang Dong, China, 516006
      • Southern Hospital of Southern Medical University
    • Guangzhou, Guang Dong, China, 519041
      • Guangdong Provincial People's Hospital
    • Shenzhen, Guang Dong, China, 518025
      • Shenzhen Second People's Hospital
  • He Nan
    • Luoyang, He Nan, China, 450052
      • First Affiliated Hospital of Henan University of Science and Technology
    • Zhengzhou, He Nan, China, 450003
      • Henan Cancer Hospital
    • Zhengzhou, He Nan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, He Nan, China, 463599
      • Henan provincial people's hospital
  • Hei Long Jiang
    • Harbin, Hei Long Jiang, China, 150010
      • Harbin First Hospital
  • Hu Bei
    • Wuhan, Hu Bei, China, 30030
      • TongJi Medical College of HUST
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410035
      • Changsha Third Hospital
  • Ji Lin
    • Chang chun, Ji Lin, China, 130061
      • The First Hospital of Jilin University
  • Jiang Su
    • Xuzhou, Jiang Su, China, 221004
      • The Affiliated Hosptial Of XuZhou Medical University
  • Jiang XI
    • Nanchang, Jiang XI, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • The First Affiliated Hospital of China Medical University
  • Shaan XI
    • Xian, Shaan XI, China, 710068
      • Shaanxi Provincial People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
  • Shan Dong
    • Jinan, Shan Dong, China, 250063
      • Cheeloo College of Medicine, Shandong University
    • Qingdao, Shan Dong, China, 266003
      • The Affiliated Hospital of Medical College Qingdao University
    • Tai'an, Shan Dong, China, 271099
      • The Second Affiliated Hospital of Shandong First Medical University
    • Taian, Shan Dong, China, 271099
      • Taian City Central Hospital
  • Shan XI
    • Taiyuan, Shan XI, China, 30032
      • Shanxi Bethune Hospital
  • Shang Hai
    • Shanghai, Shang Hai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Shanghai, Shang Hai, China, 200065
      • Tongji Hospital of Tongji University
    • Shanghai, Shang Hai, China, 200120
      • Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
  • Shanghai
    • Shanghai, Shanghai, China, 201306
      • Shanghai Sixth People's Hospital
  • Si Chuan
    • Chengdu, Si Chuan, China, 610044
      • West China Hospital of Sichuan University
    • Nanchong, Si Chuan, China, 637000
      • Affiliated Hospital of North Sichuan Medical College
  • Tian Jin
    • Tianjin, Tian Jin, China, 300052
      • Tianjin Medical University General Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Hematology Hospital of Chinese Academy of Medical Sciences
  • Zhe Jiang
    • Hangzhou, Zhe Jiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University Medical College
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical College

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lemzoparlimab in combination with AZA	Drug: Lemzoparlimab+Azacitidine (AZA); Lemzoparlimab is administered by intravenous (IV) infusion once a week at a dose of 30 mg/kg in 28-day treatment cycles; 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)	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

• Sponsor: TJ Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

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 (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Hematologic Diseases; Precancerous Conditions; Bone Marrow Diseases; Syndrome; Preleukemia; Myelodysplastic Syndromes; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Azacitidine
• 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