Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)

A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)

This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the study is to examine the safety and determine the recommended Phase 2 dose of lenzilumab when administered to subjects with previously treated CMML who meet the entry criteria. Study will begin enrollment in July 2016.

Inclusion Criteria:

• Confirmed diagnosis of CMML
• CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2
• Able to provide bone marrow biopsy samples
• Acceptable laboratory results

Exclusion Criteria:

• Leukemia other than CMML
• Recent chemotherapy or radiation therapy (within 14 days before first dose of lenzilumab)
• Concurrent use of human granulocyte-macrophage colony-stimulating factor
• Pregnant or breastfeeding
• Know HIV virus infection
• History of another malignancy within the past 2 years (some skin cancer and prostate cancers permitted)
• Significant intercurrent illness
• History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia