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

Sponsor
Humanigen, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02546284
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
43
Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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 Outcome Measures

    1. Maximum plasma concentration (Cmax) of lenzilumab [At end of infusion or 1 hour after end of infusion on Day 1]

    2. Time to maximum plasma concentration (Tmax) of lenzilumab [Pre-dose to end of infusion or 1 hour after end of infusion on Day 1]

    3. Minimum plasma concentration (Cmin) of lenzilumab [At Day 15]

    4. 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]

    5. 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]

    6. Plasma clearance (CL) of lenzilumab [End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15]

    7. lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood) [Up to an average of 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33612
    2 Mayo Clinic Cancer Center Clinical Research Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Humanigen, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Humanigen, Inc.
    ClinicalTrials.gov Identifier:
    NCT02546284
    Other Study ID Numbers:
    • HGEN003-05
    First Posted:
    Sep 10, 2015
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Humanigen, Inc.
    CMML
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myelomonocytic, Acute
    Leukemia, Myelomonocytic, Chronic
    Leukemia, Myelomonocytic, Juvenile

    Study Results

    No Results Posted as of Feb 28, 2020