Timdarpacept (IMM01) combined with azacitidine (AZA) as first-line therapy in adults with higher risk chronic myelomonocytic leukemia (CMML): results from a prospective, multicenter, phase II study.

Authors

Liya Ma, Wei Yang, Sujun Gao, Junmin Li, Qingsong Yin, Xingli Zhao, Xiaojing Yan, Sanfang Tu, Fei Li, Haiping Yang, Ronghua Hu, Shaoyuan Wang, Zheng Dong, Xiwen Zhao, Guodong Lu, Zhuli Wu, Wenzhi Tian, Hongyan Tong, Zhijian Xiao

Published in

Experimental hematology & oncology. Volume 15. Issue 1. Oct 28, 2026. Epub Oct 28, 2026.

Abstract

Timdarpacept (IMM01) is a recombinant signal regulatory protein α-IgG1 fusion protein that exerts antitumor activity by blocking the "don't eat me" signal while simultaneously activating the "eat me" signal, inducing robust antibody-dependent cellular phagocytosis. We report the final phase II results of treatment-naïve higher risk chronic myelomonocytic leukemia (CMML) patients treated with IMM01 in combination with azacitidine.
We assessed the safety and efficacy of IMM01 in combination with azacitidine (AZA) as first-line therapy for newly diagnosed CMML patients. IMM01 was administered intravenously at 2.0 mg/kg weekly, and AZA was administered subcutaneously at 75 mg/m² on days 1-7 of each 28-day cycle.
As of the data cut-off on May 13, 2025, 24 patients were enrolled. Of 22 efficacy-evaluable patients, the overall response rate (ORR) was 72.7% (16/22; 95% CI 49.8-89.3), including 27.3% complete response (CR), 13.6% marrow CR (mCR) with hematologic improvement (HI), 4.5% HI alone, and 27.3% mCR alone. The median time to response was 1.8 months (range, 0.9-3.6), and the median duration of response was 16.9 months (95% CI 5.1-NE). Median overall survival and progression-free survival were 22.2 months (95% CI 9.0-NE) and 17.8 months (95% CI 5.3-NE), respectively. The most common grade ≥ 3 treatment-related adverse events (≥ 10%) were lymphopenia (66.7%), leukopenia (62.5%), neutropenia (62.5%), thrombocytopenia (58.3%), anemia (33.3%), and pneumonia (16.7%).
IMM01 in combination with AZA was generally well tolerated and effective in treatment-naïve higher risk CMML patients. Trial registration ClinicalTrials.gov identifier: NCT05140811.

PMID:
42958448
Bibliographic data and abstract were imported from PubMed on 30 Oct 2026.

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