drugset / Trial / NCT02222688

UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT02222688

Phase 1 Completed 26 enrolled Thomas Kipps
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of the study is to investigate the safety of the investigational agent, cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. This drug will be given to humans for the first time in this study. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.

Timeline

Start
2014-08-08
Primary completion
2017-10-10
Completion
2018-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cirmtuzumab Monoclonal antibody 0.03 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 0.24 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 1 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 8 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 16 mg/kg Intravenous
Subject Cirmtuzumab Monoclonal antibody 20 mg/kg Intravenous