Actively Recruiting
Outpatient Epcoritamab as 2L in NTE R/R DLBCL
Led by Massachusetts General Hospital · Updated on 2026-02-24
30
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Outpatient Epcoritamab as 2L in NTE R/R DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of large B-cell lymphoma with one of the following subtypes: diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high grade B-cell lymphoma not otherwise specified, EBV-positive DLBCL, primary mediastinal B-cell lymphoma, T-cell/histiocyte rich large B-cell lymphoma, grade 3B follicular lymphoma, or transformed large B-cell lymphoma from indolent NHL
- Measurable disease by PET scan according to Lugano criteria
- Relapsed or refractory disease after one prior systemic anti-cancer treatment including an anti-CD20 antibody and chemotherapy
- ECOG performance status of 0 to 2
- Not a candidate for high dose chemotherapy and autologous stem cell transplant or refusal of these treatments
- Adequate blood counts: absolute neutrophil count ≥1,000/mcL, platelets ≥75,000/mcL (≥50,000 if bone marrow involvement or splenomegaly), hemoglobin ≥8 g/dL (≥7 g/dL if bone marrow involvement)
- Adequate organ function: total bilirubin ≤1.5 times upper limit normal (ULN), AST and ALT ≤3 times ULN, creatinine clearance ≥45 mL/min, normal PT and PTT unless on anticoagulation
- Ability to stay within 60 minutes of the treatment site for 24 hours after Cycle 1 Day 15 dose
- Women of childbearing potential must use effective contraception during and for 6 months after treatment and have a negative pregnancy test
- Men must use contraception during and for 3 months after treatment and agree not to donate sperm
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of investigational drugs or approved lymphoma therapies within 28 days prior to study drug, except steroids which must be stopped at least 7 days prior
- Prior treatment with CD20/CD3 bispecific antibodies, stem cell transplant, or anti-CD19 CAR T-cell therapy
- Unresolved side effects from prior cancer treatments greater than Grade 1 (except alopecia) unless approved by principal investigator
- Known central nervous system involvement by lymphoma
- Life-threatening illness or organ dysfunction that could compromise safety or study participation
- Active uncontrolled infection or autoimmune disease (some controlled autoimmune disease allowed)
- History of allergic reaction to similar compounds to epcoritamab
- Pregnant or breastfeeding women
- Active uncontrolled HIV, hepatitis B or C infection
- Active severe COVID-19 infection or recent exposure without negative testing
- Receipt of live vaccines within 28 days prior to study drug
- Any other malignancy except certain treated cancers with complete response for over 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Actively Recruiting
Research Team
J
Julie E. Haydu, MD, PhD
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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