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

Phase 1

Completed

• Conditions: Chronic Myelomonocytic Leukemia (CMML)
• Interventions: Drug: lenzilumab

• Registration Number: NCT02546284
• Lead Sponsor: Humanigen, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Study Start: 2016-07
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Agent lenzilumab	lenzilumab	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.

Primary Outcome Measures

Name	Time	Method
Safety of lenzilumab (as measured by the number of participants with adverse events) at various doses in order to determine a recommended Phase 2 dose	Up to an average of 12 months

Secondary Outcome Measures

Name	Time	Method
Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)	Up to an average of 12 months

Trial Locations

Locations (2)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Mayo Clinic Cancer Center Clinical Research; 🇺🇸 Rochester, Minnesota, United States