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Myelodysplastic Syndromes(MDS)Phase 3NCT05709093

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 Phase 3 study testing Lemzoparlimab+Azacitidine (AZA) and Azacitidine (AZA) in people with Myelodysplastic Syndromes(MDS), run by TJ Biopharma Co., Ltd. at 44 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes(MDS)
What is being tested?
Lemzoparlimab+Azacitidine (AZA) and Azacitidine (AZA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
44 sitesChina
Study dates
30 Mar 2023to 1 Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

  • Beijing Gaobo Boren Hospital Co., Ltd

    Beijing, Beijing Municipality, 100070

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, Anhui, 233099

  • The first hospital of Jilin University

    Changchun, Jilin, 130061

  • Changsha Third Hospital

    Changsha, Hunan, 410035

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • The First Affiliated Hospital of PLA Army Military Medical University

    Chongqing, Chong Qing, 400037

  • The Second Affiliated Hospital of Army Medical University

    Chongqing, Chong Qing, 400037

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chong Qing, 400042

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510260

  • Southern Hospital of Southern Medical University

    Guangzhou, Guangdong, 516006

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang, 310003

  • Harbin First Hospital

    Harbin, Heilongjiang, 150010

  • The First Affilated Hospital Of USTC Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • THE First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230022

  • Cheeloo College of Medicine, Shandong University

    Jinan, Shandong, 250063

  • First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 450052

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, Shandong, 266003

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200120

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 201306

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110002

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518025

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271099

  • Taian City Central Hospital

    Taian, Shandong, 271099

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 30032

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The First Affiliated Hospital Of WenZhou Medical College

    Wenzhou, Zhejiang, 325015

  • Tongji Medical College of HUST

    Wuhan, Hubei, 30030

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaan XI, 710068

  • The Second Affiliated Hospital of Xi'an Jiaotong University Medical College

    Xi'an, Shaanxi, 710004

  • The Affiliated Zhongshan Hospital of Xiamen University

    Xiamen, Fujian, 61004

  • The Affiliated Hosptial Of XuZhou Medical University

    Xuzhou, Jiangsu, 221004

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599

Other trials in China

About this study

Official title: 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.

Being tested
Lemzoparlimab+Azacitidine (AZA), Azacitidine (AZA)
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lemzoparlimab+Azacitidine (AZA)Drug

    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.

  • Azacitidine (AZA)Drug

    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.

Study groups in NCT05709093
Study groupRoleWhat they receive
Lemzoparlimab in combination with AZAExperimentalNot described
Receives: Drug: Lemzoparlimab+Azacitidine (AZA)
AZA monotherapyActive comparatorNot described
Receives: Drug: Azacitidine (AZA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Overall Survival(OS)

    Measured: From date of randomization until the date of first documented progression or date from any cause,whichever came first, assessed up to 50 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start30 Mar 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Why it stopped: Company Development strategy adjustment\]

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709093
Sponsor's protocol ID
TJ011133MDS301
Status last verified
Apr 2025
First submitted
10 Jan 2023
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lemzoparlimab+Azacitidine (AZA) and Azacitidine (AZA) in people with Myelodysplastic Syndromes(MDS), run by TJ Biopharma Co., Ltd. at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company Development strategy adjustment\]). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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