Outpatient Epcoritamab as 2L in NTE R/R DLBCL

NCT06811272 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.

Conditions

Relapsed Large B-cell Lymphoma; Refractory Large B-cell Lymphoma

Keywords

Non-Transplant Eligible; Second Line Therapy; DLBCL; HGBCL

Outcome Measures

Primary Outcomes (1)

• 12-month progression free survival (PFS)

  The time from registration to the earlier of progression or death due to any cause and will be defined as the percent of patients alive and progression-free at 12 months. Participants alive without disease progression are censored at date of last disease evaluation.

  Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment.

Secondary Outcomes (11)

• Complete Response Rate

  Day 1 to 24 months post treatment

• Overall Response Rate

  Day 1 to 24 months post treatment

• Median Duration of Response

  Date of first response to first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months post treatment

• Median Duration of Complete Response

  Date of complete response to first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months post treatment

• Overall Survival

  Registration date to date of death from any cause or last known alive date, assessed up to 24 months post treatment

Study Arms (1)

Epcoritamab

EXPERIMENTAL

Epcoritamab will be a subcutaneous injection on cycle 1-3 days 1, 8, 15, and 22, cycle 4-9 days 1 and 15, and cycle 10 and onwards day 1. Participants in a complete response will discontinue epcoritamab therapy after 12 cycles. Participants in a partial response or with stable disease at 1 year will continue epcoritamab and will discontinue at 18 or 24 months if in a complete response by those timepoints, otherwise they will continue until progression or intolerance. Dexamethasone (prophylactic corticosteroid) will be given during initial doses of study treatment. Dexamethasone will be taken either once daily or twice daily while receiving epcoritamab. A drug diary will be provided to participants to document information about dexamethasone being taken.

Drug: Epcoritamab

Interventions

Epcoritamab DRUG

Bispecific IgG1 antibody

Epcoritamab

Eligibility Criteria

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

You may qualify if:

• Participants must have large B-cell lymphoma of one of the following histologic subtypes by WHO criteria:
• Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
• High grade B-cell lymphoma (HGBCL) with rearrangements of MYC and BCL2 and/or BCL6
• HGBCL NOS
• EBV+ DLBCL
• Primary mediastinal B-cell lymphoma
• T-cell/histiocyte rich LBCL
• Grade 3B follicular lymphoma
• Large B-cell lymphoma transformed from underlying indolent NHL
• PET measurable disease per Lugano criteria.
• Relapsed or refractory disease treated with 1 prior systemic antineoplastic line of therapy that includes an anti-CD20 monoclonal antibody and an anthracycline or an alkylating agent. Patients who have received more than 1 prior systemic antineoplastic line of therapy are not eligible.
• Age ≥18 years.
• ECOG performance status 0-2.
• Not a candidate for high dose chemotherapy and autologous stem cell transplant per the treating investigator, or patient refusal of high dose chemotherapy and autologous transplant.
• Participants must meet the following organ and marrow function as defined below:

You may not qualify if:

• Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped at least 7 days prior to the first dose of study drug.
• Participants must not have received prior CD20/CD3 bispecific antibody.
• Participants must not have received prior autologous or allogeneic stem cell transplant.
• Participants must not have received prior anti-CD19 CAR T-cell therapy.
• Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. At the discretion of the overall PI, participants with residual toxicities \> Grade 1 may be considered eligible if in the opinion of the overall PI the residual toxicity is not likely to interfere with the safety or efficacy assessment of the investigational regimen. For residual hematologic toxicities greater than Grade 1.
• Participants must not have known central nervous system involvement by lymphoma.
• Participants must not have a current life-threatening illness, medical condition, or organ system dysfunction (other than the disease under study) which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk. Patients that have mild cognitive impairment or dementia are eligible per investigators' opinion.
• Participants must not have an uncontrolled active infection. Localized fungal infection of skin or nails are permitted.
• Participants must not have active uncontrolled autoimmune disease. Autoimmune disease under control with chronic systemic corticosteroids at a dose of 10 mg/day of prednisone or less, or equivalent corticosteroid, are eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab. A history of an infusion reaction to CD20-directed therapy is not considered an allergic reaction.
• Women who are pregnant are excluded from this study because it is unknown if epcoritamab can cause embryo-fetal harm when administered to a pregnant woman. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with epcoritamab, breastfeeding should be discontinued if the mother is treated with epcoritamab on study.
• Participant must not have active uncontrolled HIV infection. Participants with HIV are eligible if disease is adequately controlled on an antiretroviral regimen that is in accordance with the current international AIDS Society guidelines, with adequate control defined by presence of both an undetectable viral load, a CD4 count \>350, no evidence of AIDS-defining illness (with the exception of a lymphoma diagnosis), and no active opportunistic infections (infections controlled on appropriate anti-infective therapy are permitted).
• Participant must not have active hepatitis B infection. Participants with positive HBV core antibody or HBV surface antigen at screening are eligible if HBV viral load is negative by PCR and they are on appropriate antiviral therapy.
• Participant must not have active hepatitis C infection. Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Note: Participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
• Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or has had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements/recommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria: No signs/symptoms suggestive of active SARS-CoV-2 infection AND negative testing (molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genmab: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

RECRUITING

Study Officials

• Julie E. Haydu, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie E. Haydu, MD, PhD

CONTACT

617-724-4000; julie_haydu@mgh.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: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)