Trials / Recruiting
RecruitingNCT06647862
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMM01 | IV infusion |
| DRUG | Azacitidine | subcutaneous injection |
| DRUG | Placebo | IV infusion |
Timeline
- Start date
- 2024-11-11
- Primary completion
- 2026-04-24
- Completion
- 2029-10-24
- First posted
- 2024-10-18
- Last updated
- 2025-11-25
Locations
43 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06647862. Inclusion in this directory is not an endorsement.