Clinical Trials /

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

NCT02546284

Description:

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

Related Conditions:
  • Chronic Myelomonocytic Leukemia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Lenzilumab (KB003) in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
  • Official Title: A Phase 1 Study of Lenzilumab (KB003) in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)

Clinical Trial IDs

  • ORG STUDY ID: KB003-05
  • NCT ID: NCT02546284

Conditions

  • Chronic Myelomonocytic Leukemia (CMML)

Interventions

DrugSynonymsArms
lenzilumabKB003, Monoclonal AntibodySingle Agent lenzilumab

Purpose

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 (KB003) when administered to subjects with previously treated CMML who meet
      the entry criteria. Study will begin enrollment in July 2016.
    

Trial Arms

NameTypeDescriptionInterventions
Single Agent lenzilumabExperimentalDose 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.
  • lenzilumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Time Frame:Up to an average of 12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)
Time Frame:Up to an average of 12 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:KaloBios Pharmaceuticals

Trial Keywords

  • CMML

Last Updated

March 13, 2017