Actively Recruiting
A Phase 2 Trial Investigating Epcoritamab Treatment in Patients With Previously Treated Waldenstrom Macroglobulinemia
Led by Gottfried von Keudell, MD PhD · Updated on 2026-03-13
20
Participants Needed
3
Research Sites
35 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
Researchers are evaluating epcoritamab, a bispecific antibody that activates the immune system to target cancer cells, in people with previously treated Waldenstrom Macroglobulinemia (WM), a type of B-cell lymphoproliferative disorder. This prospective Phase 2 trial aims to determine if epcoritamab can be used to treat WM patients who have had prior therapies including anti-CD20 antibodies and BTK inhibitors. The study is funded by Genmab, Inc. and includes about 20 participants. Participants will receive epcoritamab through subcutaneous injections following a structured dosing schedule over up to 12 cycles (each cycle is 28 days). The treatment starts with more frequent dosing in cycles 1 to 3, then less frequent dosing in cycles 4 to 9, and finally monthly dosing in cycles 10 to 12. Study procedures include baseline and follow-up CT scans and bone marrow biopsies. The trial includes a safety lead-in dose escalation phase to find the recommended dose, followed by a phase 2 treatment period. After treatment, participants will have follow-up visits every 3 months for 2 years. During the study, participants undergo various assessments such as blood tests, electrocardiograms, bone marrow biopsies, and questionnaires to monitor health and response. Researchers will measure overall response rate after up to 12 treatment cycles as the primary outcome, along with other outcomes like progression-free survival and toxicity rates. The total participation can last over two years including treatment and follow-up. Safety and treatment effects will be carefully monitored throughout the trial.
CONDITIONS
Brief Title
Epcoritamab in Previously Treated WM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lymphoplasmacytic lymphoma/Waldenstrom Macroglobulinemia confirmed by bone marrow biopsy with CD20 positivity
- Serum IgM level greater than 2 times the upper limit of normal
- Meets criteria for treatment initiation including symptoms or organ dysfunction related to WM
- At least one prior therapy including an anti-CD20 antibody and a BTK inhibitor
- Age 18 years or older
- ECOG performance status of 2 or less
- Life expectancy greater than 2 years
- Adequate blood counts and organ function as defined in the protocol
- No active hepatitis B or C infection
- History of prior malignancy allowed if treated curatively and disease-free for at least 2 years
- Ability and willingness to provide informed consent
- Females of childbearing potential must agree to highly effective birth control methods
- Men must agree to use barrier contraception if sexually active with women of childbearing potential
- Patients with stable HIV on antiretroviral therapy with undetectable viral load and adequate CD4 count
You will not qualify if you...
- Disease transformed to aggressive lymphoma
- Symptomatic or suspected hyperviscosity syndrome with IgM levels over 4000 mg/dL without ability to undergo plasmapheresis
- Receiving other investigational agents
- Insufficient washout period from prior BTKi or rituximab therapy
- Unresolved toxicities greater than Grade 1 from prior anti-cancer therapy except alopecia and peripheral neuropathy
- Uncontrolled active infections requiring hospitalization or intravenous antibiotics within 4 weeks
- Uncontrolled significant cardiac conditions
- History of uncontrolled neurologic disorders
- Need for supplemental oxygen at rest
- Recent chronic immunosuppressive therapy unrelated to WM
- Known or suspected CNS involvement or leptomeningeal disease
- Pregnant or breastfeeding women or unwillingness to use effective contraception
- Known current alcohol or drug abuse, psychiatric illness, or unstable social situation limiting compliance
- History of allergic reactions to similar compounds as epcoritamab
- Recent exposure to live or live attenuated vaccines within 4 weeks before treatment start
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive epcoritamab injections according to a 28-day cycle schedule, with multiple doses in early cycles and fewer doses in later cycles, for up to 12 cycles (approximately 4 months). Study procedures include CT scans and bone marrow biopsies at baseline, before cycle 6, and at the end of treatment.
Weekly visits during cycles 1 to 3, then biweekly visits during cycles 4 to 9, and monthly visits during cycles 10 to 12
Duration - 24 months
Participants are followed every 3 months for 2 years after completing treatment to monitor health and disease status.
Quarterly visits for 2 years
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
D
Dea hunsicker, MSN
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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