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

November 23, 2025 updated by: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
    • 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:
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete remission( CR) rate
Time Frame: approximately 24 months
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;
approximately 24 months
Overall survival (OS)
Time Frame: approximately 24 months
Overall survival (OS): Time from randomization to death from any cause;
approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Red blood cell transfusion independence (RTI)
Time Frame: approximately 24 months
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 Frame: approximately 24 months
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 Frame: approximately 24 months
Time from randomization to transformation to AML or death from any cause, whichever occurs first
approximately 24 months
Progression-free survival(PFS)
Time Frame: approximately 24 months
Time from randomization to transformation to AML or death from any cause, whichever occurs first
approximately 24 months
Time to response (TTR)
Time Frame: approximately 24 months
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)
Time Frame: approximately 24 months
is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI
approximately 24 months
Duration of response(DOR)
Time Frame: approximately 24 months
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
Time Frame: approximately 24 months
CR rate determined by IRC based on IWG2006 MDS efficacy evaluation criteria assessed by the investigator;
approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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