Clinical Trial 18382

Cancer Type: Malignant Hematology
Interventions:KB003

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • David Sallman

Overview

Study Title

A Phase 1 Study of KB003 in Patients with Previously Treated Chronic Myelomonocytic Leukemia (CMML)

Summary

The purpose of this study is to determine if KB003 is safe in participants with a blood cancer called Chronic Myelomonocytic Leukemia, (CMML), and to determine the best dose level of study drug to be tested in a larger number of participants. This study will also look at any possible effect that KB003 may have on CMML.

Objective

Primary Objectives: The primary objective is to evaluate the safety profile and determine the recommended Phase 2 dose (RP2D) of KB003 in patients with previously treated CMML. Secondary Objectives: To assess preliminary efficacy of KB003 in patients with previously treated CMML. To evaluate the PK and immunogenicity of KB003 in patients with previously treated CMML.

Inclusion Criteria

  • Confirmed diagnosis of Chronic Myelomonocytic Leukemia (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 less than or equal to 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