A Phase I clinical trial has recently been launched by investigators at the University of California, San Diego School of Medicine (CA, USA) with an aim of assessing the safety and efficacy of the new agent cirmtuzumab (UC-961) in patients with chronic lymphocytic leukemia (CLL).
“The trial will involve patients with relapsed or refractory CLL, who will receive an intravenous infusion every 14 days at Moores, followed by regular monitoring and clinic visits to assess efficacy and identify and manage any adverse effects. Initial treatment is planned for two months,” explained Michael Choi (UC San Diego Moores Cancer Center), co-principal investigator of the clinical trial.
Cirmtuzumab is a new monoclonal antibody therapy that was developed by Thomas Kipps at UC San Diego Moores Cancer Center. The development of the agent was funded by a HALT leukemia grant awarded to Dennis Carson and Catriona Jamieson (UC San Diego Moores Cancer Center) by the California Institute for Regenerative Medicine.
The therapy is targeted to the ROR1 protein, which is normally only active during embryonic development but has been demonstrated to be exploited by cancer cells to promote tumor growth and metastasis. This association with tumor growth has lead researchers to the conclusion that ROR1 may be a biomarker of cancer stem cells and also a feasible target for the development of anticancer therapies.
Previous preclinical investigations carried out by Kipps’ team found ROR1 singularly expressed on CLL and several other cancers, including those of the breast, pancreas, colon, lung and ovary. When combined with oncogene action in mouse models of CLL, ROR1 was demonstrated to act as an accelerant of aggressive cancer growth.
“The primary goal of this Phase I clinical trial is to evaluate whether cirmtuzumab is a safe and well-tolerated cancer stem cell-targeted agent in patients with CLL,” explained Jamieson.