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

Status: Active

Description

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

Eligibility Criteria

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

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

Trial Objectives and Outline

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 Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Humanigen, Inc.

Trial IDs

Primary ID HGEN003-05
Secondary IDs NCI-2016-00003, KB003-05
Clinicaltrials.gov ID NCT02546284