Actively Recruiting
A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-13
35
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating epcoritamab as a second-line treatment for patients with follicular lymphoma who did not achieve a complete response after initial chemoimmunotherapy. This phase 2, single-arm, open-label trial is studying a bispecific antibody designed to activate the immune system to target cancer cells. The Food and Drug Administration has not approved epcoritamab for follicular lymphoma but has approved it for other conditions. Participants will receive epcoritamab through subcutaneous injections in up to 12 treatment cycles. Early cycles involve more frequent dosing, with injections on days 1, 8, 15, and 22 of a 28-day cycle, which then transitions to less frequent dosing in later cycles. Imaging scans and bone marrow biopsies occur at baseline, after certain cycles, and at the end of treatment. After completing treatment, participants will be monitored every three months for two years or until their disease worsens. During the study, participants will undergo screening visits, imaging tests such as CT, MRI, and PET scans, blood tests, electrocardiograms, and bone marrow biopsies. Questionnaires will also be collected throughout the study. Researchers will assess the complete response rate up to 12 months as the primary outcome and monitor several secondary outcomes including overall response, progression-free survival, and treatment-related toxicities. Follow-up visits will continue for up to five years to observe long-term outcomes and safety.
CONDITIONS
Brief Title
Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed follicular lymphoma grade 1-3A that is CD20 positive at diagnosis
- Measurable disease at enrollment with at least one lymph node 62;1.5 cm long axis and short axis >1.0 cm, and Deauville score 62;4 on baseline PET/CT
- Stage III or IV at initial diagnosis
- One prior line of systemic upfront therapy with anti-CD20 antibody combined with chemotherapy (minimum 3 cycles)
- Achieved partial response or stable disease after upfront treatment (no progressive disease)
- Completed all prior anti-lymphoma therapy at least 4 weeks before starting epcoritamab
- Age 18 years or older
- ECOG performance status 0 to 2
- Life expectancy greater than 2 years
- Adequate organ and marrow function as defined by specified blood counts and lab values
- Negative or controlled hepatitis B or C status with appropriate antiviral therapy if needed
- Prior malignancy allowed if treated with curative intent and no evidence of disease for 2 years
- Resolved toxicities from prior therapy to baseline or grade 61;1 (except grade 2 peripheral neuropathy or any grade alopecia)
- Ability to understand and sign informed consent
- Females of childbearing potential must agree to highly effective birth control during and 12 months after treatment
- Women must agree not to donate eggs and men must agree not to donate sperm during and 12 months after treatment
- Sexually active men with women of childbearing potential must use barrier contraception during and 12 months after treatment
You will not qualify if you...
- Use of investigational agents in prior induction therapy
- Uncontrolled active infections requiring hospitalization or IV antibiotics within 4 weeks prior to treatment
- Uncontrolled cardiac conditions including severe heart failure, recent myocardial infarction, unstable angina, or serious arrhythmias
- History of uncontrolled neurologic disorders such as seizures, stroke, psychosis, dementia, CNS vasculitis, or encephalitis
- Ejection fraction below 45% or need for supplemental oxygen at rest to maintain adequate oxygen levels
- Recent immunosuppressive therapy for non-lymphoma or lymphoma indications above specified doses
- Known or suspected central nervous system lymphoma involvement or leptomeningeal disease
- Pregnant or breastfeeding women or those unwilling to follow birth control guidelines
- Known current alcohol or drug abuse, psychiatric illness, or unstable social situations limiting study compliance
- History of allergic reactions to compounds similar to epcoritamab
- Exposure to live or live attenuated vaccines within 4 weeks
- Patients with HIV infection are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 12 cycles of 28 days each
Participants receive epcoritamab injections as treatment for follicular lymphoma over multiple cycles.
Weekly visits during Cycles 1-3, twice monthly visits during Cycles 4-9, and monthly visits during Cycles 10-12
Duration - Up to 2 years
Participants are followed for disease status and safety every 3 months for 2 years or until disease worsens.
Quarterly visits for up to 2 years
Trial Site Locations
Total: 3 locations
1
Stanford
Stanford, California, United States, 94305
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here