IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

A Randomized, Controlled, Double-Blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of IMM01 (Timdarpacept) in Combination With Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myelomonocytic Leukemia
• Intervention / Treatment: Drug: Placebo; Drug: IMM01; Drug: Azacitidine

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yujuan Ma; Phone Number: 86-15021694761; Email: yujuan.ma@immuneonco.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Peking University People's Hospital
    • Contact: qian Jiang
  • Tianjin, China
    • Recruiting
    • Tianjin People's Hospital
    • Contact: xingli Zhao
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: xiaoyu zhu
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • China-Japan Friendship Hospita
      • Contact: zhenling li
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Li Wang
  • Gansu
    • Lanzhou, Gansu, China
      • Not yet recruiting
      • First Hospital of Lanzhou University
      • Contact: bei liu
  • Gaungxi
    • Nanning, Gaungxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: zhenfang liu
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: dan xu
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen Second People's Hospital
      • Contact: xin Du
    • Zhujiang, Guangdong, China
      • Not yet recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: chaoyang Song
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: xin Du
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Affiliated Hospital of Guizhou Medical University
      • Contact: Jishi Wang
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: jinhai Ren
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • Affiliated Hospital of Hebei University
      • Contact: hua xue
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • Harbin First Hospital
      • Contact: tiejun Gong
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Contact: hu Zhou
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: zunmin Zhu
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: lijie Han
      • Principal Investigator: xinsheng Xie
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science And Technology
      • Contact: haiping Yang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
      • Contact: weiming Li
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Zhongnan Hospital Affiliated to Wuhan University
      • Contact: fuling Zhou
    • Xiangyang, Hubei, China
      • Recruiting
      • Xiangyang Central Hospital
      • Contact: guolin yuan
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Xiangya Hospital Central South University
      • Contact: yajing xu
      • Contact: zhiping jiang
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • Changzhou First People's Hospital
      • Contact: weiying gu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Jiangsu Province Hospital
      • Contact: wenyi shen
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital Affiliated to Southeast University
      • Contact: zheng Ge
    • Suzhou, Jiangsu, China
      • Not yet recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: miao miao
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Affiliated Hospital of Xuzhou Medical University
      • Contact: zhenyu li
    • Yangzhou, Jiangsu, China
      • Recruiting
      • Jiangsu Subei People's Hospital
      • Contact: mei sun
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of NanChang University
      • Contact: Fei Li
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: hai Lin
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital Of China Medical University
      • Contact: wei Yang
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • The First Hospital of China Medical University
      • Contact: xiaojing Yan
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: qiang song
  • Shanxi
    • Xi’an, Shanxi, China
      • Recruiting
      • Shaanxi Provincial People's Hospital
      • Contact: yi wang
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Provincial People's Hospital
      • Contact: xiaobing huang
    • Yibin, Sichuan, China
      • Recruiting
      • Yibin Second People's Hospital
      • Contact: shihua huang
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;
      • Contact: Zhijian Xiao, PHD; Phone Number: 022-23909184; Email: zjxiao@ihcams.ac.cn
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
      • Contact: jianping hao
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Zeping Zhou
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: hongyan Tong, PHD; Phone Number: 0571-87235589; Email: hongyantong@aliyun.com
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo First Hospital
      • Contact: guifang ouyang
    • Wenzhou, Zhejiang, China
      • Not yet recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Songfu Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old, regardless of gender;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy ≥ 12 weeks;
• Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
• White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed).
• Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy<1 cycle, and the washout period should be more than 28 days, which is acceptable.), allogeneic stem cell transplant for CMML. Note: During screening and study participation, subjects may continue oral corticosteroids for diseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study.

Exclusion Criteria:

• Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
• History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
• Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded;
• Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma;
• Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer,Surgery-cured prostate cancer and papillary thyroid cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMM01 in combination with azacitidine; One treatment cycle consists of 4 weeks (28 days). IMM01(timdarpacept) will be administered once weekly, and azacitidine will be administered from Day 1 to Day 7 of each cycle.	Drug: IMM01; IV infusion; Other Names: Timdarpacept; Drug: Azacitidine; subcutaneous injection
Placebo Comparator: placebo in combination with azacitidine; One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and azacitidine will be administered on days 1-7 of each cycle.	Drug: Placebo; IV infusion; Drug: Azacitidine; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remission( CR) rate	CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;	approximately 24 months
Overall survival (OS)	Overall survival (OS): Time from randomization to death from any cause;	approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cell transfusion independence (RTI)	the proportion of patients who did not receive red blood cell (or whole blood) transfusion for 8 consecutive weeks during the study treatment period among patients who required transfusion at baseline.	approximately 24 months
Time to transformation to acute myeloid leukemia	Time from initiation of study treatment to transformation to AML; defined as ≥ 20% blasts in the bone marrow or peripheral blood by manual differential count, according to the 2016 WHO classification criteria.	approximately 24 months
Event-free survival(EFS)	Time from randomization to transformation to AML or death from any cause, whichever occurs first	approximately 24 months
Progression-free survival(PFS)	Time from randomization to transformation to AML or death from any cause, whichever occurs first	approximately 24 months
Time to response (TTR)	time from first dose to first occurrence of CR, partial remission (PR), marrow complete remission (mCR) ± hematologic improvement (HI), HI, assessed by IRC and investigators, respectively	approximately 24 months
overall response rate(ORR)	is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI	approximately 24 months
Duration of response(DOR)	is defined as the time from the first occurrence of CR, PR, mCR±HI, or HI to disease progression or death from any cause, whichever occurs first	approximately 24 months
Complete remission(CR) rate	CR rate determined by IRC based on IWG2006 MDS efficacy evaluation criteria assessed by the investigator;	approximately 24 months

Collaborators and Investigators

• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
• Investigators: Principal Investigator: zhijian xiao, PHD, institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Principal Investigator: Hongyan Tong, PHD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): April 24, 2026
• Study Completion (Estimated): October 24, 2029

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelomonocytic, Chronic; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Azacitidine
• Other Study ID Numbers: IMM01-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No