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NCT05451810Active, not recruitingPhase 2

A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
184 (estimated)
First submitted
6 Jul 2022
Start date
17 Aug 2022
Primary completion date
Mar 2027
Lead sponsor
Genmab
NCT number
NCT05451810

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 184
  • From 17 Aug 2022 to the primary completion date, Mar 2027
  • 72 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If participant has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.

Other illness

  • Have a primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.

Who the study is looking for

  • Life expectancy \>3 months on standard of care (SOC) treatment.
  • Meets the following disease activity criteria:
    • \-- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL):
    • Documented CD20+ mature B-cell neoplasm according to the the 5th edition of World Health Organization (WHO) classification of Haematolymphoid Tumours, based on most recent representative pathology report;
    • Diffuse large B-cell lymphoma, not otherwise specified (NOS) (de novo or transformed from follicular lymphoma (FL) or Marginal Zone Lymphoma \[MZL\]);
    • High-grade B-cell Lymphoma including "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2022 or 2016 as high-grade B-cell lymphoma \[HGBCL\], with MYC and BCL2 and/or BCL6 translocations).
    • Follicular large B-cell lymphoma (FLBL, formerly FL grade 3B);
    • Relapsed or refractory disease and previously treated with at least 1 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
    • Either failed prior autologous hematopoietic stem cell transplantation (HSCT), or ineligible for autologous HSCT including but not limited to age, Eastern Cooperative Oncology Group (ECOG) performance status, participant decision, comorbidities and/or insufficient response to prior treatment.
  • R/R Follicular Lymphoma:
    • Documented CD20+ mature B-cell neoplasm according to the 5th edition of WHO classification of Haematolymphoid Tumours, based on representative pathology report;
    • \--- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation;
    • Relapsed or refractory disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
    • Previously treated with an alkylating agent or lenalidomide;
    • Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy.
  • Has at least one target lesion defined as:
    • \>= 1 measurable nodal lesion (long axis \> 1.5 cm) and/or \>= 1 measurable extranodal lesion (long axis \> 1.0 cm) on CT (or MRI) AND
    • FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
  • Must have ECOG performance status 0 - 2.
  • Must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug:
    • Absolute neutrophil count (ANC) \>= 1.0 × 10\^9/L (growth factor support allowed in case of bone marrow involvement, but participant must have not received growth factor within 14 days prior to screening lab collection);
    • Hemoglobin \>= 8.0 g/dL (RBC transfusions permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
    • Platelet count \>= 75 × 10\^9/L, or \>= 50 × 10\^9/L in the presence of bone marrow involvement or splenomegaly (platelet transfusions are permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
    • International normalized ratio (INR) (or Prothrombin Time \[PT\]) and aPTT \<= 1.5 × upper limit of normal (ULN), unless receiving anticoagulation
    • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) \<= 3.0 × upper limit of normal (ULN); unless due to hepatic involvement of disease or non-hepatic origin. For participants with hepatic involvement of disease, serum AST and serum ALT \<= 5.0 × ULN
    • Direct bilirubin \<= 2 × ULN;
    • Estimated creatine clearance (CrCl) as calculated by Cockcroft-Gault Formula \>= 45 mL/min, or estimated glomerular filtration rate (eGFR) as calculated by Modification of Diet in Renal Disease \[MDRD\] equation \>= 45 mL/min;
    • Lymphocyte count \< 5 × 10\^9/L.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (72)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pan American Center for Oncology Trials, LLC /ID# 254952
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Rio PiedrasPuerto RicoUnknown status
Auxilio Mutuo Cancer Center /ID# 254953
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San JuanPuerto RicoUnknown status
University of New Mexico /ID# 252434
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AlbuquerqueUnited StatesUnknown status
Lehigh Valley Hospital-Cedar Crest /ID# 244984
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AllentownUnited StatesUnknown status
Emory University, Winship Cancer Institute /ID# 246056
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AtlantaUnited StatesUnknown status
Texas Oncology - Austin Midtown /ID# 247656
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AustinUnited StatesUnknown status
Our Lady Of The Lake Regional Medical Center /ID# 255008
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Baton RougeUnited StatesUnknown status
American Oncology Partners of Maryland /ID# 244968
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BethesdaUnited StatesUnknown status
Beverly Hills Cancer Center /ID# 255327
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Beverly HillsUnited StatesUnknown status
Beth Israel Deaconess Medical Center /ID# 248651
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BostonUnited StatesUnknown status
Massachusetts General Hospital /ID# 245239
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BostonUnited StatesUnknown status
Tufts Medical Center /ID# 246074
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BostonUnited StatesUnknown status
Rocky Mountain Cancer Centers - Boulder /ID# 247653
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BoulderUnited StatesUnknown status
St. Luke's Hospital - Chesterfield /ID# 247815
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ChesterfieldUnited StatesUnknown status
University of Illinois at Chicago /ID# 245038
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ChicagoUnited StatesUnknown status
Oncology Hematology Care, Inc. /ID# 246182
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CincinnatiUnited StatesUnknown status
Maryland Oncology Hematology /ID# 254192
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ColumbiaUnited StatesUnknown status
OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803
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ColumbusUnited StatesUnknown status
Texas Oncology - Dallas - Worth Street /ID# 262956
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DallasUnited StatesUnknown status
University of Texas Southwestern Medical Center /ID# 244552
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DallasUnited StatesUnknown status
Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659
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DallasUnited StatesUnknown status
University of Iowa Health Care /ID# 258227
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Des MoinesUnited StatesUnknown status
Spoknwrd Clinical Trials /ID# 265232
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EastonUnited StatesUnknown status
Willamette Valley Cancer Institute and Research Center /ID# 246410
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EugeneUnited StatesUnknown status
Parkview Comprehensive Cancer Center /ID# 244545
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Fort WayneUnited StatesUnknown status
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
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Fountain ValleyUnited StatesUnknown status
UCSF Fresno /ID# 263286
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FresnoUnited StatesUnknown status
Virginia Cancer Specialists - Gainesville /ID# 248760
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GainesvilleUnited StatesUnknown status
Cancer & Hematology Centers of Western Michigan - East /ID# 244985
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Grand RapidsUnited StatesUnknown status
Prisma Health /ID# 247654
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GreenvilleUnited StatesUnknown status
East Carolina University - Brody School of Medicine /ID# 248989
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GreenvilleUnited StatesUnknown status
The John Theurer Cancer /ID# 262532
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HackensackUnited StatesUnknown status
Hattiesburg Clinic /ID# 244980
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HattiesburgUnited StatesUnknown status
Penn State Milton S. Hershey Medical Center /ID# 244979
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HersheyUnited StatesUnknown status
Indiana Blood & Marrow Transpl /ID# 244971
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IndianapolisUnited StatesUnknown status
Cancer Specialists of North Florida /ID# 261842
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JacksonvilleUnited StatesUnknown status
Florida Cancer Specialists /ID# 260854
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Lake MaryUnited StatesUnknown status
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003
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LebanonUnited StatesUnknown status
NHO - Nebraska Hematology-Oncology /ID# 263164
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LincolnUnited StatesUnknown status
University of Arkansas for Medical Sciences /ID# 244562
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Little RockUnited StatesUnknown status
University of California, Los Angeles /ID# 244573
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Los AngelesUnited StatesUnknown status
The West Clinic /ID# 245004
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MemphisUnited StatesUnknown status
Mount Sinai Medical Center-Miami Beach /ID# 249045
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Miami BeachUnited StatesUnknown status
Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630
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MobileUnited StatesUnknown status
Morristown Medical Center /ID# 244973
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MorristownUnited StatesUnknown status
Vanderbilt University Medical Center /ID# 260953
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NashvilleUnited StatesUnknown status
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681
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New Hyde ParkUnited StatesUnknown status
New York Cancer and Blood Specialists - New York /ID# 264676
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New YorkUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai /ID# 258610
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New YorkUnited StatesUnknown status
Stony Brook University Medical Center /ID# 244631
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New YorkUnited StatesUnknown status
Illinois Cancer Specialists /ID# 247655
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NilesUnited StatesUnknown status
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514
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NorfolkUnited StatesUnknown status
University of Oklahoma, Stephenson Cancer Center /ID# 244568
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Oklahoma CityUnited StatesUnknown status
Memorial Hospital West /ID# 248432
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Pembroke PinesUnited StatesUnknown status
UPMC Hillman Cancer Ctr /ID# 244571
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PittsburghUnited StatesUnknown status
New York Cancer and Blood Specialists /ID# 259016
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Port Jefferson StationUnited StatesUnknown status
Blue Ridge Cancer Center /ID# 260597
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RoanokeUnited StatesUnknown status
Oregon Oncology Specialists in Salem /ID# 260570
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SalemUnited StatesUnknown status
Texas Oncology - San Antonio Medical Center /ID# 247658
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San AntonioUnited StatesUnknown status
Highlands Oncology Group, PA /ID# 245002
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SpringdaleUnited StatesUnknown status
Bennett Cancer Center - Stamford Hospital /ID# 244530
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StamfordUnited StatesUnknown status
Northwest Medical Specialties - Tacoma /ID# 245045
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TacomaUnited StatesUnknown status
BRCR Medical Center Inc /ID# 262527
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TamaracUnited StatesUnknown status
New York Cancer and Blood Specialists - Bronx /ID# 264690
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The BronxUnited StatesUnknown status
Toledo Clinic Cancer Center - Main /ID# 246852
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ToledoUnited StatesUnknown status
Texas Oncology - Northeast Texas /ID# 247657
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TylerUnited StatesUnknown status
MedStar Washington Hospital Center /ID# 246068
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Washington D.C.United StatesUnknown status
Cleveland Clinic Florida /ID# 244532
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WestonUnited StatesUnknown status
Reading Hospital; McGlinn Cancer Institute /ID# 259181
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West ReadingUnited StatesUnknown status
Wake Forest Univ HS /ID# 245005
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Winston-SalemUnited StatesUnknown status
Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.