A Phase I/II Study of IMO-8400 in Patients with Persistent or Recurrent Waldenstrom's Macroglobulinemia

Full Title

Phase 1/2 Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients with Relapsed or Refractory Waldenström’s Macroglobulinemia


Waldenstrom’s macroglobulinemia (WM) is a cancer of white blood cells called B lymphocytes. The purpose of this study is to find the highest dose of an investigational drug called IMO-8400 that can be given safely in patients with WM that has continued to grow or has come back despite prior therapy, and to observe the preliminary effectiveness of this drug in these patients.

IMO-8400 works by targeting proteins called Toll-like receptor 7 (TLR7), TLR8, and TLR9, which appear to be overactive in most patients with WM. Laboratory studies of WM showed that IMO-8400 resulted in tumor cell death. The drug is given as a subcutaneous (under the skin) injection.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have WM that has continued to grow or has come back following at least one previous regimen of therapy.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. M. Lia Palomba at 212-639-7186.