A Phase 1b-2 Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab, and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With B-Cell Lymphoid Malignancies
18 Years and older, Male and Female
CIRM-0001 (primary)
NCI-2018-00270
Summary
This is a Phase 1b / 2 study to investigate the safety and effectiveness of the investigational drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR1) that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell signaling that cause leukemia cells to grow and survive. ROR1 is rarely found on healthy cells.
Objectives
This is a Phase 1b/2 study to investigate the safety and effectiveness of the investigational
drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid
malignancies. The Phase 1b will be conducted in two parts (Part 1 and Part 2). Part 1 is a
dose-finding evaluation of the sequential administration of cirmtuzumab monotherapy followed
by cirmtuzumab and ibrutinib combination therapy in chronic lymphocytic leukemia/small
lymphocytic leukemia (CLL/SLL) or or previously treated mantle cell lymphoma (MCL) subjects
who have not received prior Bruton tyrosine kinase (BTK) inhibitor therapy. Up to 48 subjects
will be enrolled in Part 1 to determine the recommended dosing regimen (RDR). In Part 2, up
to 18 subjects will be enrolled to further evaluate the safety and pharmacology of the
cirmtuzumab and ibrutinib combination given at the RDR determined in Part 1 of the study. In
the Phase 2 (Part 3) portion of the study, approximately 90 subjects with MCL will be
randomized to either Arm 1 (cirmtuzumab and ibrutinib) at the RDR or Arm 2 (ibrutinib alone)
to evaluate the clinical activity and safety of the two arms.
Treatment Sites in Georgia
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