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

A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)

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

Study Overview

• Status: Completed
• Conditions: Chronic Myelomonocytic Leukemia (CMML)
• Intervention / Treatment: Drug: lenzilumab

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Agent 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.	Drug: lenzilumab; Other Names: Monoclonal Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of lenzilumab	At end of infusion or 1 hour after end of infusion on Day 1
Time to maximum plasma concentration (Tmax) of lenzilumab	Pre-dose to end of infusion or 1 hour after end of infusion on Day 1
Minimum plasma concentration (Cmin) of lenzilumab	At Day 15
Area under the plasma concentration curve (AUC) of lenzilumab	Predose, end of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Plasma half life (t ½) of lenzilumab	End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Plasma clearance (CL) of lenzilumab	End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood)	Up to an average of 12 months

Collaborators and Investigators

• Sponsor: Humanigen, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: CMML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid; Leukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile
• Other Study ID Numbers: HGEN003-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No