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AzTrials

Chronic Myelomonocytic LeukemiaPhase 3NCT06647862

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

A Phase 3 study testing IMM01 and Azacitidine in people with Chronic Myelomonocytic Leukemia, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 43 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myelomonocytic Leukemia
What is being tested?
IMM01 and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
43 sitesChina
Study dates
11 Nov 2024to 24 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

43 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yujuan Ma contact

86-15021694761

yujuan.ma@immuneonco.com

43 sites in 1 country

China43 sites, 43 recruiting

  • China-Japan Friendship Hospita

    Beijing, Beijing Municipality

    zhenling li

    Recruiting

  • Peking University People's Hospital

    Beijing

    qian Jiang

    Not yet recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    hai Lin

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    yajing xu

    zhiping jiang

    Not yet recruiting

  • Changzhou First People's Hospital

    Changzhou, Jiangsu

    weiying gu

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    xiaobing huang

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    li wang

    Not yet recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    dan xu

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangzhou

    xin Du

    Recruiting

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    jishi wang

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    hongyan Tong, PHD, 0571-87235589, hongyantong@aliyun.com

    Recruiting

  • Harbin First Hospital

    Harbin, Heilongjiang

    tiejun Gong

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    xiaoyu zhu

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    qiang song

    Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    zeping Zhou

    Not yet recruiting

  • First Hospital of Lanzhou University

    Lanzhou, Gansu

    bei liu

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    fei Li

    Not yet recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    wenyi shen

    Not yet recruiting

  • Zhongda Hospital affiliated to Southeast University

    Nanjing, Jiangsu

    zheng Ge

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Gaungxi

    zhenfang liu

    Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejiang

    guifang ouyang

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    wei Yang

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    xiaojing Yan

    Not yet recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

    xin du

    Not yet recruiting

  • Affiliated Hospital of Hebei University

    Shijiazhuang, Hebei

    hua xue

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    jinhai Ren

    Not yet recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    miao miao

    Not yet recruiting

  • Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;

    Tianjin, Tianjin Municipality, 300020

    Zhijian Xiao, PHD, 022-23909184, zjxiao@ihcams.ac.cn

    Recruiting

  • Tianjin People's Hospital

    Tianjin

    xingli Zhao

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    jianping hao

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    songfu jiang

    Not yet recruiting

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

    Wuhan, Hubei

    weiming Li

    Recruiting

  • Zhongnan Hospital Affiliated to Wuhan University

    Wuhan, Hubei

    fuling Zhou

    Not yet recruiting

  • Shaanxi Provincial People's Hospital

    Xi’an, Shanxi

    yi wang

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei

    guolin yuan

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    zhenyu li

    Recruiting

  • Jiangsu Subei People's Hospital

    Yangzhou, Jiangsu

    mei sun

    Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan

    shihua huang

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    lijie Han

    xinsheng Xie

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    hu Zhou

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    zunmin Zhu

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan

    haiping Yang

    Not yet recruiting

  • Zhujiang Hospital of Southern Medical University

    Zhujiang, Guangdong

    chaoyang Song

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
IMM01, Azacitidine, Placebo
Medical subject headings
Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM01Drug

    Also called Timdarpacept

    IV infusion

  • AzacitidineDrug

    subcutaneous injection

  • PlaceboDrug

    IV infusion

Study groups in NCT06647862
Study groupRoleWhat they receive
IMM01 in combination with azacitidineExperimentalOne 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.
Receives: Drug: IMM01; Drug: Azacitidine
placebo in combination with azacitidinePlacebo comparatorOne 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.
Receives: Drug: Azacitidine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission( CR) rate

    CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;

    Measured: approximately 24 months

  2. Overall survival (OS)

    Overall survival (OS): Time from randomization to death from any cause;

    Measured: approximately 24 months

Secondary outcomes (8)

  1. Event-free survival(EFS)

    Time from randomization to transformation to AML or death from any cause, whichever occurs first

    Measured: approximately 24 months

  2. Progression-free survival(PFS)

    Time from randomization to transformation to AML or death from any cause, whichever occurs first

    Measured: approximately 24 months

  3. 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

    Measured: approximately 24 months

  4. overall response rate(ORR)

    is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI

    Measured: approximately 24 months

  5. 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

    Measured: approximately 24 months

  6. 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.

    Measured: approximately 24 months

  7. Complete remission(CR) rate

    CR rate determined by IRC based on IWG2006 MDS efficacy evaluation criteria assessed by the investigator;

    Measured: approximately 24 months

  8. 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.

    Measured: approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start11 Nov 2024
  3. Primary completion24 Apr 2026 (estimated)
  4. Study completion24 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647862
Sponsor's protocol ID
IMM01-010
Status last verified
Nov 2025
First submitted
16 Oct 2024
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMM01 and Azacitidine in people with Chronic Myelomonocytic Leukemia, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 43 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yujuan Ma (86-15021694761, yujuan.ma@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission( CR) rate (time frame: approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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