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

NCT02546284 | Completed Phase 1 FDA Drug

• 1 other identifier: HGEN003-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Myelomonocytic Leukemia (CMML)

Keywords

CMML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Single Agent lenzilumab

EXPERIMENTAL

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

Interventions

lenzilumab DRUG

Also known as: Monoclonal Antibody

Single Agent lenzilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanigen, Inc.: lead

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Mayo Clinic Cancer Center Clinical Research

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

lenzilumab; Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 10, 2015
• Study Start: July 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)