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Clinical Trials in the USA / NCT05451810
Active, not recruiting Phase 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

NCT05451810 · tracked via the Priya Life Science USA tracker
Sponsor
Genmab
Phase
Phase 2
Started
2022-08-17
Last updated
2026-09-11

Condition(s) studied

Diffuse Large B-Cell LymphomaClassic Follicular Lymphoma

Investigational drug(s) / intervention(s)

Epcoritamab

Epcoritamab: Subcutaneous Injection (SC)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 Mobile Alabama
University of Arkansas for Medical Sciences /ID# 244562 Little Rock Arkansas
Highlands Oncology Group, PA /ID# 245002 Springdale Arkansas
Beverly Hills Cancer Center /ID# 255327 Beverly Hills California
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 Fountain Valley California
UCSF Fresno /ID# 263286 Fresno California
University of California, Los Angeles /ID# 244573 Los Angeles California
Rocky Mountain Cancer Centers - Boulder /ID# 247653 Boulder Colorado
Bennett Cancer Center - Stamford Hospital /ID# 244530 Stamford Connecticut
MedStar Washington Hospital Center /ID# 246068 Washington D.C. District of Columbia
Cancer Specialists of North Florida /ID# 261842 Jacksonville Florida
Florida Cancer Specialists /ID# 260854 Lake Mary Florida
Mount Sinai Medical Center-Miami Beach /ID# 249045 Miami Beach Florida
Memorial Hospital West /ID# 248432 Pembroke Pines Florida
BRCR Medical Center Inc /ID# 262527 Tamarac Florida
Cleveland Clinic Florida /ID# 244532 Weston Florida
Emory University, Winship Cancer Institute /ID# 246056 Atlanta Georgia
University of Illinois at Chicago /ID# 245038 Chicago Illinois
Illinois Cancer Specialists /ID# 247655 Niles Illinois
Parkview Comprehensive Cancer Center /ID# 244545 Fort Wayne Indiana
Indiana Blood & Marrow Transpl /ID# 244971 Indianapolis Indiana
University of Iowa Health Care /ID# 258227 Des Moines Iowa
Our Lady Of The Lake Regional Medical Center /ID# 255008 Baton Rouge Louisiana
American Oncology Partners of Maryland /ID# 244968 Bethesda Maryland
Maryland Oncology Hematology /ID# 254192 Columbia Maryland
Tufts Medical Center /ID# 246074 Boston Massachusetts
Massachusetts General Hospital /ID# 245239 Boston Massachusetts
Beth Israel Deaconess Medical Center /ID# 248651 Boston Massachusetts
Cancer & Hematology Centers of Western Michigan - East /ID# 244985 Grand Rapids Michigan
Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547 Ypsilanti Michigan
Hattiesburg Clinic /ID# 244980 Hattiesburg Mississippi
St. Luke's Hospital - Chesterfield /ID# 247815 Chesterfield Missouri
NHO - Nebraska Hematology-Oncology /ID# 263164 Lincoln Nebraska
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003 Lebanon New Hampshire
The John Theurer Cancer /ID# 262532 Hackensack New Jersey
Morristown Medical Center /ID# 244973 Morristown New Jersey
University of New Mexico /ID# 252434 Albuquerque New Mexico
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681 New Hyde Park New York
Stony Brook University Medical Center /ID# 244631 New York New York
New York Cancer and Blood Specialists - New York /ID# 264676 New York New York

+ 32 more sites — see the full list on the official registry below.

More Genmab trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05451810 on ClinicalTrials.gov ↗ ← All trials in the USA