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RecruitingNCT06647862Updated Nov 25, 2025

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

A Phase 3 interventional study of IMM01 and Azacitidine in Chronic Myelomonocytic Leukemia, sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.. Recruiting at 43 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 remission rate and Overall survival.

02

Conditions studied

  • Chronic Myelomonocytic Leukemia
03

In context

Leukemia, Myelomonocytic, Chronic

329 studies on the registry are indexed under Leukemia, Myelomonocytic, Chronic; 67 are open to participants now.

This study's planned enrollment of 170 is above the median of 42 across 297 interventional studies indexed under Leukemia, Myelomonocytic, Chronic.

Browse Leukemia, Myelomonocytic, Chronic studies →

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc. is the lead sponsor of 21 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
170 participants (estimated)

Study arms

  • 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 · Drug: Azacitidine

  • 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: Azacitidine · Drug: Placebo

Interventions

  • DrugIMM01

    IV infusion

    Also known as: Timdarpacept

  • DrugAzacitidine

    subcutaneous injection

  • DrugPlacebo

    IV infusion

06

What researchers measure

Primary outcomes

  1. Complete remission( CR) rate

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

    Time frame: approximately 24 months

  2. Overall survival (OS)

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

    Time frame: approximately 24 months

Secondary outcomes

  1. Event-free survival(EFS)

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

    Time frame: approximately 24 months

  2. Progression-free survival(PFS)

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

    Time frame: 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

    Time frame: approximately 24 months

  4. overall response rate(ORR)

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

    Time frame: 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

    Time frame: 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.

    Time frame: approximately 24 months

  7. Complete remission(CR) rate

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

    Time frame: 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.

    Time frame: approximately 24 months

07

Study locations

24 of 43 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui, China
    • xiaoyu zhu · Contact
    Recruiting
  • China-Japan Friendship Hospita
    Beijing, Beijing Municipality, China
    • zhenling li · Contact
    Recruiting
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China
    • li wang · Contact
    Not yet recruiting
  • First Hospital of Lanzhou University
    Lanzhou, Gansu, China
    • bei liu · Contact
    Not yet recruiting
  • The First Affiliated Hospital of Guangxi Medical University
    Nanning, Gaungxi, China
    • zhenfang liu · Contact
    Recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong, China
    • dan xu · Contact
    Recruiting
  • Shenzhen Second People's Hospital
    Shenzhen, Guangdong, China
    • xin du · Contact
    Not yet recruiting
  • Zhujiang Hospital of Southern Medical University
    Zhujiang, Guangdong, China
    • chaoyang Song · Contact
    Not yet recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangzhou, China
    • xin Du · Contact
    Recruiting
  • Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou, China
    • jishi wang · Contact
    Recruiting
  • Affiliated Hospital of Hebei University
    Shijiazhuang, Hebei, China
    • hua xue · Contact
    Not yet recruiting
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    • jinhai Ren · Contact
    Not yet recruiting
  • Harbin First Hospital
    Harbin, Heilongjiang, China
    • tiejun Gong · Contact
    Not yet recruiting
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    • lijie Han · Contact
    • xinsheng Xie · Principal investigator
    Recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan, China
    • hu Zhou · Contact
    Recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
    • zunmin Zhu · Contact
    Not yet recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Zhengzhou, Henan, China
    • haiping Yang · Contact
    Not yet recruiting
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    • weiming Li · Contact
    Recruiting
  • Zhongnan Hospital Affiliated to Wuhan University
    Wuhan, Hubei, China
    • fuling Zhou · Contact
    Not yet recruiting
  • Xiangyang Central Hospital
    Xiangyang, Hubei, China
    • guolin yuan · Contact
    Recruiting
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
    • yajing xu · Contact
    • zhiping jiang · Contact
    Not yet recruiting
  • Changzhou First People's Hospital
    Changzhou, Jiangsu, China
    • weiying gu · Contact
    Recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
    • wenyi shen · Contact
    Not yet recruiting
  • Zhongda Hospital affiliated to Southeast University
    Nanjing, Jiangsu, China
    • zheng Ge · Contact
    Recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    • miao miao · Contact
    Not yet recruiting
  • Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
    • zhenyu li · Contact
    Recruiting
  • Jiangsu Subei People's Hospital
    Yangzhou, Jiangsu, China
    • mei sun · Contact
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    • fei Li · Contact
    Not yet recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin, China
    • hai Lin · Contact
    Recruiting
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning, China
    • wei Yang · Contact
    Recruiting
  • The First Hospital of China Medical University
    Shenyang, Liaoning, China
    • xiaojing Yan · Contact
    Not yet recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    • qiang song · Contact
    Recruiting
  • Shaanxi Provincial People's Hospital
    Xi’an, Shanxi, China
    • yi wang · Contact
    Recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
    • xiaobing huang · Contact
    Not yet recruiting
  • Yibin Second People's Hospital
    Yibin, Sichuan, China
    • shihua huang · Contact
    Recruiting
  • Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;
    Tianjin, Tianjin Municipality 300020, China
    Recruiting
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang, China
    • jianping hao · Contact
    Recruiting
  • The Second Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan, China
    • zeping Zhou · Contact
    Not yet recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310003, China
    Recruiting
  • Ningbo First Hospital
    Ningbo, Zhejiang, China
    • guifang ouyang · Contact
    Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
    • songfu jiang · Contact
    Not yet recruiting
  • Peking University People's Hospital
    Beijing, China
    • qian Jiang · Contact
    Not yet recruiting
  • Tianjin People's Hospital
    Tianjin, China
    • xingli Zhao · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06647862
Lead sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Nov 11, 2024
Primary completion
Apr 24, 2026 (estimated)
Completion
Oct 24, 2029 (estimated)
Last update
Nov 25, 2025

Study contacts

Yujuan Ma
Contact
yujuan.ma@immuneonco.com
86-15021694761
zhijian xiao, PHD
principal investigator · Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Hongyan Tong, PHD
principal investigator · Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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