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

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

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

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02546284.

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.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationHumanigen, Inc.

Description