Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1 Extension Study to Determine the Safety of UC-961 (Cirmtuzumab) at the Recommended Phase 2 Dose for Retreatment of Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961
The purpose of the study is to investigate the safety of the investigational drug called
cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called
a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on
the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of
the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the
cancer cells. Cirmtuzumab is considered experimental because its use is not approved by
United States (US) Food and Drug Administration (FDA).
Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the
number of CLL cells, the investigators do not know if this will work in humans. Therefore,
the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants
when given for a duration of 6 to 12 months.
This is an open-label extension study to determine the safety and tolerability of cirmtuzumab
given to participants who enrolled and completed the initial phase 1 trial in CLL without a
dose-limiting toxicity.
UC-961 is administered by intravenous infusion every 14 days for 4 doses, then every 28 days
for 4 doses, after which responses will be assessed. Patients with an objective response
(meeting working group criteria for partial response or complete response) will continue at
the same dose and schema. Patients with stable disease or progressive disease are eligible to
increase the dose of UC-961 for another 6-month course.
Duration of UC-961 administration is until disease progression, treatment intolerance, or
lack of clinical benefit.
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