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

NCT06647862 | Recruiting Phase 3

• 1 other identifier: IMM01-010
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Chronic Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Event-free survival(EFS)

  approximately 24 months

• Progression-free survival(PFS)

  approximately 24 months

• Time to response (TTR)

  approximately 24 months

• overall response rate(ORR)

  approximately 24 months

• Duration of response(DOR)

  approximately 24 months

Study Arms (2)

IMM01 in combination with azacitidine

EXPERIMENTAL

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 in combination with azacitidine

PLACEBO COMPARATOR

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

IMM01 DRUG

IV infusion

Also known as: Timdarpacept

IMM01 in combination with azacitidine

Azacitidine DRUG

subcutaneous injection

IMM01 in combination with azacitidine; placebo in combination with azacitidine

Placebo DRUG

IV infusion

placebo in combination with azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

Study Sites (43)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

China-Japan Friendship Hospita

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Gaungxi, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China

RECRUITING

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Affiliated Hospital of Hebei University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

Harbin First Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

NOT YET RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Zhongnan Hospital Affiliated to Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Changzhou First People's Hospital

Changzhou, Jiangsu, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Zhongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Jiangsu Subei People's Hospital

Yangzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Yibin Second People's Hospital

Yibin, Sichuan, China

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

RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujuan Ma

CONTACT

86-15021694761; yujuan.ma@immuneonco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: November 11, 2024
• Primary Completion: April 24, 2026
• Study Completion (Estimated): October 24, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (43)