Tests timdarpacept with azacitidine in newly diagnosed chronic myelomonocytic leukemia
Tests timdarpacept plus azacitidine against placebo plus azacitidine in adults with chronic myelomonocytic leukemia.
Plain-language title generated from the registry record
Registry title: IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
Key facts
- Where
- Beijing, Changchun, Changsha, Changzhou, Chengdu, Chongqing, Guangzhou, Guiyang, Hangzhou, Harbin, Hefei, Jinan, Kunming, Lanzhou, Nanchang, Nanjing, Nanning, Ningbo, Shenyang, Shenzhen, Shijiazhuang, Suzhou, Tianjin, Ürümqi, Wenzhou, Wuhan, Xi'an, Xiangyang, Xuzhou, Yangzhou, Yibin, Zhengzhou, and Zhujiang, ChinaSee the 43 sites
- Phase
- Phase 3
Where in China
- China-Japan Friendship HospitaBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaNot yet recruiting
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaNot yet recruiting
- Changzhou First People's HospitalChangzhou, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaNot yet recruiting
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Harbin First HospitalHarbin, ChinaNot yet recruiting
- Anhui Provincial HospitalHefei, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaNot yet recruiting
- First Hospital of Lanzhou UniversityLanzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaNot yet recruiting
- Jiangsu Province HospitalNanjing, ChinaNot yet recruiting
- Zhongda Hospital Affiliated to Southeast UniversityNanjing, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Ningbo First HospitalNingbo, ChinaTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaNot yet recruiting
- Shenzhen Second People's HospitalShenzhen, ChinaNot yet recruiting
- Affiliated hospital of Hebei UniversityShijiazhuang, ChinaNot yet recruiting
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaNot yet recruiting
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
- Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;Tianjin, ChinaTaking people
- Tianjin People's HospitalTianjin, ChinaTaking people
- The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNot yet recruiting
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- Zhongnan Hospital Affiliated to Wuhan UniversityWuhan, ChinaNot yet recruiting
- Shaanxi provincial people's hospitalXi'an, ChinaTaking people
- Xiangyang Central HospitalXiangyang, ChinaTaking people
- Affiliated Hospital of Xuzhou Medical UniversityXuzhou, ChinaTaking people
- Jiangsu Subei People's HospitalYangzhou, ChinaTaking people
- Yibin Second People's HospitalYibin, ChinaTaking people
- First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Henan University of Science and TechnologyZhengzhou, ChinaNot yet recruiting
- Zhujiang hospital of Southern Medical UniversityZhujiang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Trial code
- NCT06647862
- Record updated
- 25 November 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein; 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; 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; History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant; Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma.