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)

Sponsor

I-Mab Biopharma Co. Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05709093

Collaborator

(none)

552

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes(MDS)	Drug: Lemzoparlimab+Azacitidine (AZA) Drug: Azacitidine (AZA)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

552 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Mar 31, 2027

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital Of Bengbu Medical College	Bengbu	An Hui	China	233099
2	THE First Affiliated Hospital Of Anhui Medical University	Hefei	An Hui	China	230022
3	The First Affilated Hospital Of USTC Anhui Provincial Hospital	Hefei	Anhui	China	230001
4	Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Bei Jing	China	100037
5	Beijing Gaobo Boren Hospital Co., Ltd	Beijing	Bei Jing	China	100070
6	Peking University Third Hospital	Beijing	Bei Jing	China	100191
7	The First Affiliated Hospital of PLA Army Military Medical University	Chongqing	Chong Qing	China	400037
8	The Second Affiliated Hospital of Army Medical University	Chongqing	Chong Qing	China	400037
9	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chong Qing	China	400042
10	The Affiliated Zhongshan Hospital of Xiamen University	Xiamen	Fu Jian	China	61004
11	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guang Dong	China	510120
12	Zhujiang Hospital of Southern Medical University	Guangzhou	Guang Dong	China	510260
13	Southern Hospital of Southern Medical University	Guangzhou	Guang Dong	China	516006
14	Guangdong Provincial People's Hospital	Guangzhou	Guang Dong	China	519041
15	Shenzhen Second People's Hospital	Shenzhen	Guang Dong	China	518025
16	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	He Nan	China	450052
17	Henan Cancer Hospital	Zhengzhou	He Nan	China	450003
18	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	He Nan	China	450052
19	Henan Provincial People's Hospital	Zhengzhou	He Nan	China	463599
20	Harbin First Hospital	Harbin	Hei Long Jiang	China	150010
21	Tongji Medical College of HUST	Wuhan	Hu Bei	China	30030
22	Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
23	Changsha Third Hospital	Changsha	Hunan	China	410035
24	The first hospital of Jilin University	Chang chun	Ji Lin	China	130061
25	The Affiliated Hosptial Of XuZhou Medical University	Xuzhou	Jiang Su	China	221004
26	The First Affiliated Hospital of Nanchang University	Nanchang	Jiang XI	China	330006
27	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110002
28	Shaanxi Provincial People's Hospital	Xian	Shaan XI	China	710068
29	The Second Affiliated Hospital of Xi'an Jiaotong University Medical College	Xi'an	Shaanxi	China	710004
30	Cheeloo College of Medicine, Shandong University	Jinan	Shan Dong	China	250063
31	The Affiliated Hospital of Medical College Qingdao University	Qingdao	Shan Dong	China	266003
32	The Second Affiliated Hospital of Shandong First Medical University	Tai'an	Shan Dong	China	271099
33	Taian City Central Hospital	Taian	Shan Dong	China	271099
34	Shanxi Bethune Hospital	Taiyuan	Shan XI	China	30032
35	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shang Hai	China	200025
36	Tongji Hospital of Tongji University	Shanghai	Shang Hai	China	200065
37	Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University	Shanghai	Shang Hai	China	200120
38	Shanghai Sixth People's Hospital	Shanghai	Shanghai	China	201306
39	West China Hospital of Sichuan University	Chengdu	Si Chuan	China	610044
40	West China Hospital of Sichuan University	Chengdu	Si Chuan	China	610044
41	Affiliated Hospital of North Sichuan Medical College	Nanchong	Si Chuan	China	637000
42	Tianjin Medical University General Hospital	Tianjin	Tian Jin	China	300052
43	Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin	China	300020
44	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhe Jiang	China	310003
45	The First Affiliated Hospital Of WenZhou Medical College	Wenzhou	Zhejiang	China	325015

Sponsors and Collaborators

I-Mab Biopharma Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

I-Mab Biopharma Co. Ltd.

ClinicalTrials.gov Identifier:

NCT05709093

Other Study ID Numbers:

TJ011133MDS301

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 1, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Preleukemia

Myelodysplastic Syndromes

Syndrome

Azacitidine

Study Results

No Results Posted as of Feb 1, 2023