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

Humanigen

Status and phase: Completed; Phase 1

Conditions: Chronic Myelomonocytic Leukemia (CMML)

Treatments: Drug: lenzilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02546284

HGEN003-05

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single Agent lenzilumab

Experimental group

Description:

Dose levels: lenzilumab IV infusion once monthly for a 28 day dosing cycle (with extra dose on Day 15 during cycle). Three (3) to Six (6) subjects will be enrolled into planned escalating cohorts of 200 mg, 400 mg or 600 mg lenzilumab.

Treatment:

Drug: lenzilumab