Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated November 25, 2025 (before its estimated April 24, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-16; most recent amendment 2025-11-23.
Trial Details
NCT Number NCT06647862
Lead Sponsor ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Conditions Chronic Myelomonocytic Leukemia
Enrollment 170 participants
Start Date 2024-11-11
Primary Completion 2026-04-24 (estimated)
Study Completion 2029-10-24 (estimated)
Updated on ClinicalTrials.gov 2025-11-25