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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546284
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Humanigen, Inc.

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date February 28, 2020
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)		 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2015)		 Safety of KB003 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)		 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2015)		 Clinical activity of KB003 (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 ]
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2016)
  • Maximum plasma concentration (Cmax) of lenzilumab [ Time Frame: At end of infusion or 1 hour after end of infusion on Day 1 ]
  • Time to maximum plasma concentration (Tmax) of lenzilumab [ Time Frame: Pre-dose to end of infusion or 1 hour after end of infusion on Day 1 ]
  • Minimum plasma concentration (Cmin) of lenzilumab [ Time Frame: At Day 15 ]
  • Area under the plasma concentration curve (AUC) of lenzilumab [ Time Frame: 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 [ Time Frame: End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 ]
  • Plasma clearance (CL) of lenzilumab [ Time Frame: 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) [ Time Frame: Up to an average of 12 months ]
Original Other Pre-specified Outcome Measures
 (submitted: September 8, 2015)
  • Maximum plasma concentration (Cmax) of KB003 [ Time Frame: At end of infusion or 1 hour after end of infusion on Day 1 ]
  • Time to maximum plasma concentration (Tmax) of KB003 [ Time Frame: Pre-dose to end of infusion or 1 hour after end of infusion on Day 1 ]
  • Minimum plasma concentration (Cmin) of KB003 [ Time Frame: At Day 15 ]
  • Area under the plasma concentration curve (AUC) of KB003 [ Time Frame: 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 KB003 [ Time Frame: End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 ]
  • Plasma clearance (CL) of KB003 [ Time Frame: End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 ]
  • KB003 immunogenicity (as measured by antibodies against KB003 in blood) [ Time Frame: Up to an average of 12 months ]
 
Descriptive Information
Brief Title  ICMJE Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
Official Title  ICMJE A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myelomonocytic Leukemia (CMML)
Intervention  ICMJE Drug: lenzilumab
Other Name: Monoclonal Antibody
Study Arms  ICMJE 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.
Intervention: Drug: lenzilumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)		 15
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2015)		 31
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546284
Other Study ID Numbers  ICMJE HGEN003-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Humanigen, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Humanigen, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Humanigen, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP