NCT06510491

Epcoritamab in Previously Treated WM

A Phase 2 Trial Investigating Epcoritamab in Patients With Previously Treated Waldenstrom Macroglobulinemia (WM)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gottfried von Keudell, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM). The names of the study drug involved in this study is: -Epcoritamab (a type of antibody)

Detailed description

This is a prospective phase 2, single arm, open label trial to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM). Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for WM. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, electrocardiograms, bone marrow biopsies, and Computerized Tomography (CT) scans. Participants will receive study treatment for up to 4 months and will be followed for 24 months. It is expected that about 20 people will take part in this research study. Genmab, Inc. is funding this research study by providing the study drug, epcoritamab.

Conditions

• Waldenstrom Macroglobulinemia
• B-Cell Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	Epcoritamab	Bispecific antibody, via subcutaneous (under the skin) injection per protocol.

Timeline

• Start date: 2024-12-06
• Primary completion: 2027-04-30
• Completion: 2027-12-31
• First posted: 2024-07-19
• Last updated: 2026-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study