Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06510361

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-13

35

Participants Needed

3

Research Sites

179 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

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment. The name of the study drug in this research study is: -Epcoritamab (a type of antibody)

CONDITIONS

Official Title

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-confirmed follicular lymphoma grade 1-3A that is CD20 positive at diagnosis
  • Measurable disease with at least one lymph node ≥1.5 cm long axis and >1.0 cm short axis with Deauville score ≥4 on PET/CT
  • Stage III or IV follicular lymphoma at initial diagnosis
  • Received one prior line of systemic therapy including anti-CD20 antibody plus chemotherapy (at least 3 cycles)
  • Achieved partial response or stable disease after upfront treatment, not progressive disease
  • Completed prior anti-lymphoma therapy at least 4 weeks 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 blood counts and liver/kidney tests
  • If hepatitis B core antibody positive on antiviral therapy with negative PCR, must receive antiviral prophylaxis
  • Hepatitis C antibody positive with undetectable viral load
  • Prior malignancy allowed if treated with curative intent at least 2 years prior and no current disease
  • Resolved toxicities from prior therapy to baseline or grade 1 (except grade 2 peripheral neuropathy or any grade alopecia)
  • Ability to understand and sign informed consent
  • Agree to use highly effective birth control if of childbearing potential and follow contraception guidelines during and after study
Not Eligible

You will not qualify if you...

  • Use of investigational agents in prior induction therapy
  • Uncontrolled active infection requiring hospitalization or IV antibiotics within 4 weeks prior to treatment
  • Uncontrolled cardiac conditions including heart failure grade III/IV, low ejection fraction (<45%), unstable angina, recent myocardial infarction (<6 months), or arrhythmia
  • History of uncontrolled neurological conditions such as seizures, stroke, psychosis, dementia, CNS vasculitis, or encephalitis
  • Need for supplemental oxygen at rest to maintain adequate oxygen saturation
  • Immunosuppressive therapy for non-lymphoma reasons within 28 days or lymphoma reasons within 10 days before treatment
  • Known or suspected CNS involvement or leptomeningeal disease
  • Pregnant or breastfeeding women or unwillingness to follow contraception guidelines
  • Known current alcohol or drug abuse, psychiatric illness, or unstable social situation limiting study compliance
  • History of allergic reactions to compounds similar to epcoritamab
  • Exposure to live or live attenuated vaccines within 4 weeks
  • HIV infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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