drugset / Trial / NCT06647862
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-11-11
- Primary completion
- 2026-04-24
- Completion
- 2029-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMM01 | Protein / enzyme biologic | — | Intravenous |
| Background | Azacitidine | Other / unclassified | — | Subcutaneous |