Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.
This is a phase 2 study to test whether cirmtuzumab in combination with venetoclax given as consolidation therapy can decrease the number of cancer cells that may be left in the bone marrow or in the blood in patients who have been treated with venetoclax for at least one year. Consolidation therapy is given after initial cancer treatment to further reduce the number of cancer cells that may be left in the body. Cirmtuzumab, a monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor (ROR1) signaling and stemness, may be effective in reducing the risk of disease progression in patients with detectable minimal residual disease (MRD) after treatment with venetoclax.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Cycle 1, Day 1 \& 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg
Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.
UCSD Koman Family Outpatient Pavilion
San Diego, California, United States
Cancer response to treatment
Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.
Time frame: 6-24 months
Frequency of adverse events
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: 9-15 months
Time to next CLL treatment.
Measurement of time of anti-cancer activity
Time frame: 9-24 months
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