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Monoclonal Antibodies

Safety Lead-In Epcoritamab for B-Cell Lymphoma

Phase 2
Waitlist Available
Led By Gottfried von Keudell, MD
Research Sponsored by Gottfried von Keudell, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* A diagnosis of lymphoplasmacytic lymphoma/WM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy/aspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted.
* Serum IgM level \>2x upper limit of normal (ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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)

Who is the study for?
This trial is for individuals with Waldenstrom Macroglobulinemia (WM), a type of B-cell lymphoma, who have already undergone treatment. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.
What is being tested?
The trial is testing Epcoritamab, an antibody designed to target and kill cancer cells in patients with WM who have previously been treated. The goal is to see if this drug is effective as a new therapy option for these patients.
What are the potential side effects?
While specific side effects for Epcoritamab are not listed here, antibodies like it can sometimes cause reactions at the infusion site, fever, chills, nausea, fatigue, and allergic responses among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
2-year Overall Survival (OS)
2-year Progression-Free Survival (PFS) Rate
6-month Best Response Rate
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Lead-In EpcoritamabExperimental Treatment1 Intervention
Participants will be enrolled using a modified 3+3 dose-escalation design to establish the Recommended Phase 2 Dose of Epcoritamab and will complete study procedures as follows: * Baseline visit with CT scan and bone marrow biopsy. * Bone marrow biopsy before cycle 6. * Cycles 1 - 3: --Days 1, 8, 15, and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 4 - 9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 10 - 12: --Day 1 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * End of Treatment visit with CT scan and bone marrow biopsy. * Follow up visits: every 3 months for 2 years * Off study visit * If there are 0 out of 3 dose-limiting toxicities (DLTs), the study will proceed to phase II. If 1/3 participants experience a DLT, up to 3 additional participants will be treated at the same dose level. If more than 1/6 total participants experience a DLT, then the study will not proceed to phase 2.
Group II: Phase II EpcoritamabExperimental Treatment1 Intervention
Participants will be enrolled and will complete study procedures as follows: * Baseline visit with CT scan and bone marrow biopsy. * Bone marrow biopsy before cycle 6. * Cycles 1 - 3: --Days 1, 8, 15, and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 4 - 9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 10 - 12: --Day 1 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * End of Treatment visit with CT scan and bone marrow biopsy. * Follow up visits: every 3 months for 2 years * Off study visit

Find a Location

Who is running the clinical trial?

Gottfried von Keudell, MD PhDLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
GenmabIndustry Sponsor
65 Previous Clinical Trials
13,095 Total Patients Enrolled
Gottfried von Keudell, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
2 Previous Clinical Trials
62 Total Patients Enrolled
~13 spots leftby Oct 2025
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