Clinical Trial: Study of Lenzilumab (KB003) in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Study of Lenzilumab (KB003) 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 Summary: 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.
Sponsor: KaloBios Pharmaceuticals

Current Primary Outcome: 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: 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 ]

Current Secondary Outcome: 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: 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 ]

Information By: KaloBios Pharmaceuticals

Dates:
Date Received: August 27, 2015
Date Started: July 2016
Date Completion: October 2018
Last Updated: March 13, 2017
Last Verified: March 2017