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)

Myelodysplastic Syndromes(MDS) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709093
• Other study ID #: TJ011133MDS301
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: TJ Biopharma Co., Ltd.
• Contact: Shuang Li
• Phone: 18604031725
• Email: shuang.li[@]i-mabbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 552
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 SIRPa 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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Myelodysplastic Syndromes(MDS)
• Preleukemia
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Gaobo Boren Hospital Co., Ltd	Beijing	Bei Jing
China	Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Bei Jing
China	Peking University Third Hospital	Beijing	Bei Jing
China	The First Affiliated Hospital Of Bengbu Medical College	Bengbu	An Hui
China	The first hospital of Jilin University	Chang chun	Ji Lin
China	Changsha Third Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Si Chuan
China	West China Hospital of Sichuan University	Chengdu	Si Chuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chong Qing
China	The First Affiliated Hospital of PLA Army Military Medical University	Chongqing	Chong Qing
China	The Second Affiliated Hospital of Army Medical University	Chongqing	Chong Qing
China	Guangdong Provincial People's Hospital	Guangzhou	Guang Dong
China	Southern Hospital of Southern Medical University	Guangzhou	Guang Dong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guang Dong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guang Dong
China	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhe Jiang
China	Harbin First Hospital	Harbin	Hei Long Jiang
China	The First Affilated Hospital Of USTC Anhui Provincial Hospital	Hefei	Anhui
China	THE First Affiliated Hospital Of Anhui Medical University	Hefei	An Hui
China	Cheeloo College of Medicine, Shandong University	Jinan	Shan Dong
China	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	He Nan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiang XI
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Si Chuan
China	The Affiliated Hospital of Medical College Qingdao University	Qingdao	Shan Dong
China	Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University	Shanghai	Shang Hai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shang Hai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shang Hai
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen Second People's Hospital	Shenzhen	Guang Dong
China	The Second Affiliated Hospital of Shandong First Medical University	Tai'an	Shan Dong
China	Taian City Central Hospital	Taian	Shan Dong
China	Shanxi Bethune Hospital	Taiyuan	Shan XI
China	Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tian Jin
China	The First Affiliated Hospital Of WenZhou Medical College	Wenzhou	Zhejiang
China	Tongji Medical College of HUST	Wuhan	Hu Bei
China	Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University Medical College	Xi'an	Shaanxi
China	The Affiliated Zhongshan Hospital of Xiamen University	Xiamen	Fu Jian
China	Shaanxi Provincial People's Hospital	Xian	Shaan XI
China	The Affiliated Hosptial Of XuZhou Medical University	Xuzhou	Jiang Su
China	Henan Cancer Hospital	Zhengzhou	He Nan
China	Henan Provincial People's Hospital	Zhengzhou	He Nan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	He Nan

Sponsors (1)

Lead Sponsor	Collaborator
TJ Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.