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

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanigen, Inc.; KaloBios Pharmaceuticals

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