Actively Recruiting
Epcoritamab in Previously Treated WM
Led by Gottfried von Keudell, MD PhD · Updated on 2026-03-13
20
Participants Needed
3
Research Sites
160 weeks
Total Duration
On this page
Sponsors
G
Gottfried von Keudell, MD PhD
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Epcoritamab in Previously Treated WM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lymphoplasmacytic lymphoma/Waldenstrom Macroglobulinemia (WM) that is CD20 positive confirmed by bone marrow biopsy or aspirate
- Serum IgM level greater than twice the upper limit of normal
- Meet criteria for starting treatment based on IWWM2 guidelines including symptoms such as hyperviscosity, neuropathy, organ dysfunction, or constitutional symptoms
- At least one prior treatment line discontinued due to intolerance or disease progression
- Prior therapies must include an anti-CD20 antibody and a BTK inhibitor; BTK inhibitor must have a washout period of at least 4 half-lives before starting epcoritamab
- Age 18 years or older
- ECOG performance status of 0 to 2
- Life expectancy greater than 2 years
- Adequate organ and marrow function as defined by specific blood counts and lab values
- No active hepatitis B or C infection; if chronic hepatitis B, must have close monitoring and prophylactic therapy
- History of prior malignancy allowed if treatment completed at least 2 years before and no current disease
- Ability to understand and sign informed consent
- Females of childbearing potential must agree to use highly effective birth control methods
- Women must not donate eggs and men must not donate sperm during the study and for 12 months after last dose
- Men sexually active with women of childbearing potential must use barrier contraception during study and for 12 months after last dose
- Patients with HIV may enroll if on stable therapy with undetectable viral load and CD4 count over 250 cells/mm3
You will not qualify if you...
- Disease transformed to aggressive lymphoma
- Symptomatic or suspected hyperviscosity syndrome or IgM levels over 4000 mg/dL without ability to undergo plasmapheresis
- Receiving any other investigational agents
- Inadequate washout from prior BTK inhibitor or rituximab treatment
- Unresolved toxicities greater than grade 1 from prior anti-cancer therapy except alopecia and peripheral neuropathy
- Uncontrolled active infection requiring hospitalization or IV antibiotics within 4 weeks
- Uncontrolled serious cardiac conditions such as advanced heart failure, recent heart attack, unstable angina, or arrhythmias
- History of uncontrolled neurologic conditions like seizures, stroke, psychosis, dementia, CNS vasculitis, or encephalitis
- Need for supplemental oxygen at rest to maintain adequate oxygen levels
- Use of chronic immunosuppressive therapy for non-WM reasons within 28 days before treatment
- Known or suspected central nervous system involvement by lymphoma
- Pregnant or breastfeeding women or those unwilling to use effective contraception
- Known current alcohol or drug abuse, psychiatric illness, or unstable social situation likely to interfere with study compliance
- History of allergic reactions to compounds similar to epcoritamab
- Exposure to live or live attenuated vaccines within 4 weeks before starting treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
G
Gottfried von Keudell, MD, PhD
CONTACT
D
Dea hunsicker, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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