Title: A Phase 1b/2 Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab (UC-961), and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With B-Cell Lymphoid Malignancies
Principal Investigator: Michael Choi, MD, University of California, San Diego
Description: This is a phase 1b/2 study to investigate the safety and effectiveness of cirmtuzumab, an investigational drug, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Phase 1b of the trial will be conducted in 2 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 patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or previously treated mantle cell lymphoma (MCL) who have not received prior Bruton tyrosine kinase (BTK) inhibitor therapy. Up to 48 patients will be enrolled in part 1 to determine the recommended dosing regimen. In part 2 of the trial, up to 18 patients will be enrolled to further evaluate the safety and pharmacology of the combination of cirmtuzumab and ibrutinib given at the recommended dosing regimen determined in part 1 of the study. In phase 2 of the study (part 3 of the trial), approximately 90 patients with CLL/SLL who have not received prior BTK inhibitor therapy will be randomly assigned to receive either combination cirmtuzumab and ibrutinib at the recommended dosing regimen (arm 1) or ibrutinib alone (arm 2) to evaluate the clinical activity and safety of the two arms.
Status: This study is open and recruiting patients as of January 3, 2018.
This study is sponsored by University of California, San Diego.
Clinicaltrials.gov. A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies. NCT03088878. https://clinicaltrials.gov/ct2/show/NCT03088878. Accessed December 10, 2019.