Study on Epcoritamab for Patients with Previously Treated Waldenstrom Macroglobulinemia (WM)

Sponsor: Gottfried von Keudell, MD PhD

Sponsor score: 0

ClinicalTrials ID:NCT06510491

Provider View

This clinical trial is testing whether the drug epcoritamab can be used to treat patients with Waldenstrom Macroglobulinemia (WM) who have already received treatment before. Epcoritamab is a type of antibody designed to help the immune system target cancer cells.

Patient Parameters

Program Overview

The study aims to find out if epcoritamab, a special type of antibody, can be effective in treating people with Waldenstrom Macroglobulinemia (WM) who have been treated before. This trial involves various procedures like blood tests, scans, and questionnaires to monitor the participants' health and response to the treatment. Participants will receive the treatment for up to 4 months and will be followed for 24 months to check on their progress. About 20 people are expected to join this study, which is funded by Genmab, Inc.

Description

This is a phase 2 study where all participants will receive the same treatment to see if epcoritamab can help treat Waldenstrom Macroglobulinemia (WM) in patients who have already been treated before. Epcoritamab is a bispecific antibody, which means it is a lab-made protein that helps the immune system find and attack cancer cells. The U.S. Food and Drug Administration (FDA) has not yet approved epcoritamab for treating WM.

Participants will go through a series of tests and procedures, including blood tests, heart tests, bone marrow biopsies, and CT scans, to ensure they are eligible and to monitor their health during the study. The treatment will last up to 4 months, and participants will be followed for 24 months to see how they respond to the treatment. The study is expected to include about 20 participants and is funded by Genmab, Inc., which provides the study drug, epcoritamab.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Waldenstrom Macroglobulinemia (WM) with specific markers confirmed by a bone marrow biopsy.
  • High levels of a protein called IgM in the blood.
  • Need for treatment due to symptoms like nerve problems, organ issues, or other specific conditions related to WM.
  • Previously received at least one treatment for WM that was stopped due to side effects or the disease getting worse.
  • Previous treatments must have included specific drugs like rituximab and a BTK inhibitor.
  • Age 18 or older.
  • Generally good health with a performance status score of 2 or less.
  • Life expectancy of more than 2 years.
  • Meet specific blood and organ function requirements.
  • No active Hepatitis B or C infection.
  • Past cancer treatment completed at least 2 years ago with no current disease.
  • Able to understand and sign a consent form.
  • Women of childbearing potential must use effective birth control during and after the study.
  • Men must use a barrier method of birth control during and after the study.
  • HIV-positive patients can participate if they are on stable treatment and have a controlled viral load.

Exclusion Criteria

  • Disease has changed to a more aggressive form of lymphoma.
  • Cannot undergo a procedure to reduce high IgM levels if needed.
  • Currently receiving another experimental treatment.
  • Not enough time has passed since the last treatment with certain drugs.
  • Have not recovered from side effects of previous cancer treatments.
  • Have an uncontrolled infection or heart condition.
  • Have a serious neurological condition.
  • Need oxygen to maintain normal blood oxygen levels.
  • On long-term immunosuppressive therapy.
  • Have cancer that has spread to the brain or spinal cord.
  • Pregnant or breastfeeding women.
  • History of severe allergic reactions to similar drugs.
  • Recent use of live vaccines.
  • Current alcohol or drug abuse, or unstable social situation.

Locations

FACILITYZIPCITYSTATE
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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