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
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pan American Center for Oncology Trials, LLC /ID# 254952 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Auxilio Mutuo Cancer Center /ID# 254953 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of New Mexico /ID# 252434 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Lehigh Valley Hospital-Cedar Crest /ID# 244984 Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Emory University, Winship Cancer Institute /ID# 246056 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Texas Oncology - Austin Midtown /ID# 247656 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Our Lady Of The Lake Regional Medical Center /ID# 255008 Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| American Oncology Partners of Maryland /ID# 244968 Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Beverly Hills Cancer Center /ID# 255327 Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Beth Israel Deaconess Medical Center /ID# 248651 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital /ID# 245239 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tufts Medical Center /ID# 246074 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rocky Mountain Cancer Centers - Boulder /ID# 247653 Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| St. Luke's Hospital - Chesterfield /ID# 247815 Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| University of Illinois at Chicago /ID# 245038 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Oncology Hematology Care, Inc. /ID# 246182 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Maryland Oncology Hematology /ID# 254192 Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Oncology - Dallas - Worth Street /ID# 262956 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas Southwestern Medical Center /ID# 244552 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Iowa Health Care /ID# 258227 Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Spoknwrd Clinical Trials /ID# 265232 Coordinator of this site? Confirm its status | Easton | United States | Unknown status |
| Willamette Valley Cancer Institute and Research Center /ID# 246410 Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Parkview Comprehensive Cancer Center /ID# 244545 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| UCSF Fresno /ID# 263286 Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Virginia Cancer Specialists - Gainesville /ID# 248760 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Cancer & Hematology Centers of Western Michigan - East /ID# 244985 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Prisma Health /ID# 247654 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| East Carolina University - Brody School of Medicine /ID# 248989 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| The John Theurer Cancer /ID# 262532 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Hattiesburg Clinic /ID# 244980 Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Penn State Milton S. Hershey Medical Center /ID# 244979 Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Indiana Blood & Marrow Transpl /ID# 244971 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Cancer Specialists of North Florida /ID# 261842 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Florida Cancer Specialists /ID# 260854 Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003 Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| NHO - Nebraska Hematology-Oncology /ID# 263164 Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| University of Arkansas for Medical Sciences /ID# 244562 Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of California, Los Angeles /ID# 244573 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| The West Clinic /ID# 245004 Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Mount Sinai Medical Center-Miami Beach /ID# 249045 Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Morristown Medical Center /ID# 244973 Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University Medical Center /ID# 260953 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681 Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| New York Cancer and Blood Specialists - New York /ID# 264676 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai /ID# 258610 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stony Brook University Medical Center /ID# 244631 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Illinois Cancer Specialists /ID# 247655 Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514 Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| University of Oklahoma, Stephenson Cancer Center /ID# 244568 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Memorial Hospital West /ID# 248432 Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| UPMC Hillman Cancer Ctr /ID# 244571 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| New York Cancer and Blood Specialists /ID# 259016 Coordinator of this site? Confirm its status | Port Jefferson Station | United States | Unknown status |
| Blue Ridge Cancer Center /ID# 260597 Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Oregon Oncology Specialists in Salem /ID# 260570 Coordinator of this site? Confirm its status | Salem | United States | Unknown status |
| Texas Oncology - San Antonio Medical Center /ID# 247658 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Highlands Oncology Group, PA /ID# 245002 Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Bennett Cancer Center - Stamford Hospital /ID# 244530 Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| Northwest Medical Specialties - Tacoma /ID# 245045 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| BRCR Medical Center Inc /ID# 262527 Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| New York Cancer and Blood Specialists - Bronx /ID# 264690 Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Toledo Clinic Cancer Center - Main /ID# 246852 Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Texas Oncology - Northeast Texas /ID# 247657 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| MedStar Washington Hospital Center /ID# 246068 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Cleveland Clinic Florida /ID# 244532 Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Reading Hospital; McGlinn Cancer Institute /ID# 259181 Coordinator of this site? Confirm its status | West Reading | United States | Unknown status |
| Wake Forest Univ HS /ID# 245005 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547 Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.