Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies
Status:
Completed
Trial end date:
2015-10-07
Target enrollment:
Participant gender:
Summary
Previous experience with antibody therapy in both NHL and CLL warrants further exploration of
new antibody treatments for these diseases.
Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully
humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1
is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated
in clinical trials of patients with B-cell malignancies and autoimmune disorders.
This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's
lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one
prior standard treatment. All patients will receive hLL1 administered intravenously once
daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be
assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per
statistical plan) in order to determine the maximum tolerated dose (MTD) for this
administration schedule.