Evaluating IMM01 with Azacitidine for Newly Diagnosed Chronic Myelomonocytic Leukemia

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 testing if a new treatment combining IMM01 with azacitidine can help people who have just been diagnosed with chronic myelomonocytic leukemia feel better and live longer compared to those getting a placebo with azacitidine.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 43 sites (Hefei, Anhui and 42 other locations)
• Trial ID: NCT06647862 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, controlled, double-blind, multicenter phase 3 study designed to assess the efficacy of IMM01 (timdarpacept) in combination with azacitidine compared to a placebo with azacitidine in patients newly diagnosed with chronic myelomonocytic leukemia (CMML). The primary endpoints include the complete remission rate and overall survival of participants. Eligible patients must be treatment-naïve and meet specific criteria regarding their health status and blood cell counts. The study aims to provide insights into the potential benefits of this combination therapy for CMML patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed CMML who have not received prior treatment.

Not a fit: Patients who have previously been treated with hypomethylating agents, chemotherapy, or allogeneic stem cell transplant for CMML may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve remission rates and overall survival for patients with chronic myelomonocytic leukemia.

How similar studies have performed: Other studies have explored similar treatment combinations, but the specific efficacy of IMM01 with azacitidine in CMML is being evaluated for the first time in this context.

Eligibility criteria

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;

Where this trial is running

Hefei, Anhui and 42 other locations

• 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, 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, 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)

Study contacts

• Principal investigator: zhijian xiao, PHD — Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Yujuan Ma

Conditions: Chronic Myelomonocytic Leukemia