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RECRUITINGPHASE2

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

A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy

NCT06510361•Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

Summary

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)

Detailed Description

This is a prospective, phase 2, single arm, open label trial investigating epcoritamab in participants with follicular lymphoma (FL) who have failed to achieve a complete response after frontline therapy. Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for follicular lymphoma but it has been approved for other uses. The research study procedures include screening for eligibility, treatment study visits, questionnaires, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, electrocardiograms, blood tests, and bone marrow biopsies. Participants will receive treatment for up to 12 cycles and will be followed for 2 years. It is expected that about 35 people will take part in this research study. Genmab, Inc. is funding this research study by providing the study drug, Epcoritamab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.
•Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \>1.0 cm and Deauville ≥ 4 seen on baseline PET/CT
•Stage III/IV at initial diagnosis
•1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide). Rituximab monotherapy, rituximab plus radiation, or radiation alone is not sufficient.
•Subjects need to have achieved a partial response or stable disease as best response following upfront treatment. Subjects with progressive disease will be excluded.
•Subjects must have completed all prior anti-lymphoma therapy at least 4 weeks (28 days) prior to start of epcoritamab.
•Age ≥18 years.
•3.1.7 Age ≥18 years.
•ECOG performance status ≤ 2
•Life expectancy of greater than 2 years
+17 more criteria

Exclusion Criteria

•Use of investigational agents incorporated into prior induction therapy
•Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment
•Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF \<45%, unstable angina pectoris, acute myocardial infarction \< 6 months, cardiac arrhythmia
•History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis
•EF \<45% or need for supplemental O2 at rest to maintain SaO2\>89%
•Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including systemic corticosteroids 10 mg/day or greater of prednisone or equivalent
•Patients with known or suspected CNS involvement or leptomeningeal disease are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease
•Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:
•* Premenarchal
•* Postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \[FSH\] level \>40 IU/L or mIU/mL)
+6 more criteria

Locations (3)

Stanford

Stanford, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

November 20, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2028

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

LymphomaFollicular LymphomaLymphoma,Non-HodgkinLymphoma, Non-Hodgkin's, Adult

Interventions

Epcoritamab

DRUG

Contacts

Gottfried von Keudell, MD, PhD

CONTACT

617-667-9920 gkeudell@bidmc.harvard.edu

Dea Hunsicker, MSN

CONTACT

617-667-9920 dhunsick@bidmc.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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