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

NCT06510361 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-065
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief 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)

Conditions

Lymphoma; Follicular Lymphoma; Lymphoma,Non-Hodgkin; Lymphoma, Non-Hodgkin's, Adult

Keywords

Follicular Lymphoma; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Non-Hodgkin's, Adult

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  The CRR was defined as the proportion of participants achieving complete response (CR) based on Lugano Response Criteria (Adapted from Cheson, 2014).

  CRR expected to be observed up to 12 months.

Secondary Outcomes (9)

• Overall Response Rate (ORR)

  ORR expected to be observed up to 12 months.

• Median Progression-Free Survival (PFS)

  Survival collected during all visits through 24 months then every 6 months through 5 years.

• Median Overall Survival (OS)

  Survival observed up to 5 years

• Median Time to Next Treatment (TTNT)

  Up to 5 years

• Median Duration of Response (DOR)

  Observation period up to approximately 12 cycles (1 cycle being 28 days)

Study Arms (1)

Epcoritamab

EXPERIMENTAL

35 participants will be enrolled and will complete study procedures as follows: * Baseline visit with imaging (CT, MRI or PET scan) and bone marrow biopsy. * Imaging after Cycles 3 and 6 only. * Cycles 1-3: --Days 1, 8, 15 and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 4-9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 10-12: --Day 1 of 28 day cycles: Predetermined dose of Epcoritamab 1x daily * End of Treatment visit with imaging and bone marrow biopsy. * Follow up: every 3 months for 2 years or until disease worsens. * Off study visit with imaging.

Drug: Epcoritamab

Interventions

Epcoritamab DRUG

Humanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.

Also known as: DuoBody-CD3xCD20, GEN3013

Epcoritamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Age ≥18 years.
• ECOG performance status ≤ 2
• Life expectancy of greater than 2 years
• Participants must meet the following organ and marrow function as defined below:
• Absolute neutrophil count ≥1000 cells/mcl (G-CSF allowed if marrow involved with disease)
• Platelets ≥75,000 cells/mcl (transfusion allowed if marrow involved)
• Hemoglobin ≥ 8 g/dL (transfusion allowed if marrow involved)
• Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected/known Gilbert's disease total bilirubin up to 3x ULN will be allowed

You may not qualify if:

• 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 \&lt; 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)
• Permanently sterilized (e.g., bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
• Note: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.15.
• Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab
• Exposure to a live or a live attenuated vaccine within 4 weeks

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Genmab: collaborator

Study Sites (3)

Stanford

Stanford, California, 94305, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gottfried von Keudell, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: November 20, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (3)