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 23, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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