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Clinical Trials in China / NCT06647862
Recruiting Phase 3

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

NCT06647862 · tracked via the Priya Life Science China tracker
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Phase
Phase 3
Started
2024-11-11
Last updated
2025-11-25

Condition(s) studied

Chronic Myelomonocytic Leukemia

Investigational drug(s) / intervention(s)

IMM01AzacitidinePlacebo

IMM01: IV infusion

Azacitidine: subcutaneous injection

Placebo: IV infusion

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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: * 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;

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Recruiting
China-Japan Friendship Hospita Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Gaungxi Recruiting
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
Shenzhen Second People's Hospital Shenzhen Guangdong Not Yet Recruiting
Zhujiang Hospital of Southern Medical University Zhujiang Guangdong Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangzhou Recruiting
Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Recruiting
Affiliated Hospital of Hebei University Shijiazhuang Hebei Not Yet Recruiting
The Second Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Harbin First Hospital Harbin Heilongjiang Not Yet Recruiting
First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Zhengzhou Henan Not Yet Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Zhongnan Hospital Affiliated to Wuhan University Wuhan Hubei Not Yet Recruiting
Xiangyang Central Hospital Xiangyang Hubei Recruiting
Xiangya Hospital Central South University Changsha Hunan Not Yet Recruiting
Changzhou First People's Hospital Changzhou Jiangsu Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
Zhongda Hospital affiliated to Southeast University Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Not Yet Recruiting
Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting
Jiangsu Subei People's Hospital Yangzhou Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
The First Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shaanxi Provincial People's Hospital Xi’an Shanxi Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
Yibin Second People's Hospital Yibin Sichuan Recruiting
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Tianjin Tianjin Municipality Recruiting
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Recruiting
The Second Affiliated Hospital of Kunming Medical University Kunming Yunnan Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Ningbo First Hospital Ningbo Zhejiang Recruiting

+ 3 more sites — see the full list on the official registry below.

More ImmuneOnco Biopharmaceuticals (Shanghai) Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06647862 on ClinicalTrials.gov ↗ ← All trials in China