This clinical trial is for men and women with CD20+ B-cell malignancies, including B-NHL’s and CLL.
The anti-CD20 monoclonal antibody (mAb), rituximab, has dramatically improved the prognosis for patients with NHL, and has been a mainstay of treatment since its first approval in 1997. While rituximab has single-agent activity in both indolent and aggressive NHL, and more modest activity in CLL, the standard of care is to use it in combination with chemotherapy. Response rates to conventional therapy are generally greater than 50%, but most patients will relapse. In the relapsed or salvage setting, there are no standard of care options and the choice of therapy is often guided by patient clinical factors, including performance status and the presence of comorbidities. Additionally, there is a growing body of data demonstrating the development of diminished activity of rituximab and rituximab resistance over time in multiple NHL subtypes.
REGN1979 is a bispecific (anti-CD20 and anti-CD3) monoclonal antibody, designed with a novel mechanism of action that is distinct from that of other anti-CD20 antibodies, and as such may provide a therapeutic benefit in patients who have relapsed following anti-CD20 mAb therapy. This first in human phase 1 study is designed to investigate the safety and tolerability of REGN1979.
Subjects will be assigned to a dose level cohort that will consist of an initial starting dose, followed by a higher dose for all subsequent administrations. REGN1979 will be administered as an IV infusion, weekly for the first four weeks, then monthly for five months, for a total of nine doses over six months. After completing the treatment period, subjects will have follow-up visits monthly for six months.