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)

NCT05709093 | Terminated Phase 3

• 1 other identifier: TJ011133MDS301
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

Myelodysplastic Syndromes(MDS)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Lemzoparlimab in combination with AZA

EXPERIMENTAL

Drug: Lemzoparlimab+Azacitidine (AZA)

AZA monotherapy

ACTIVE COMPARATOR

Drug: Azacitidine (AZA)

Interventions

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.

Lemzoparlimab in combination with AZA

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.

AZA monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (44)

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, Anhui, 233099, China

Location

The First Affilated Hospital Of USTC Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

THE First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Beijing Gaobo Boren Hospital Co., Ltd

Beijing, Beijing Municipality, 100070, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of PLA Army Military Medical University

Chongqing, Chong Qing, 400037, China

Location

The Second Affiliated Hospital of Army Medical University

Chongqing, Chong Qing, 400037, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chong Qing, 400042, China

Location

The Affiliated Zhongshan Hospital of Xiamen University

Xiamen, Fujian, 61004, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510260, China

Location

Southern Hospital of Southern Medical University

Guangzhou, Guangdong, 516006, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518025, China

Location

Harbin First Hospital

Harbin, Heilongjiang, 150010, China

Location

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 450052, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 463599, China

Location

Tongji Medical College of HUST

Wuhan, Hubei, 30030, China

Location

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

Wuhan, Hubei, 430022, China

Location

Changsha Third Hospital

Changsha, Hunan, 410035, China

Location

The Affiliated Hosptial Of XuZhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130061, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaan XI, 710068, China

Location

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

Xi'an, Shaanxi, 710004, China

Location

Cheeloo College of Medicine, Shandong University

Jinan, Shandong, 250063, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, 266003, China

Location

Taian City Central Hospital

Taian, Shandong, 271099, China

Location

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271099, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 201306, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 30032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

Location

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The First Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital Of WenZhou Medical College

Wenzhou, Zhejiang, 325015, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 1, 2023
• Study Start: March 30, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CN (44)