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Outpatient immunotherapy tested for hard-to-treat lymphomas

NCT ID NCT05451810

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing an experimental drug called epcoritamab in adults with diffuse large B-cell lymphoma or classic follicular lymphoma that has come back or stopped responding to earlier treatments. The trial gives the drug as an injection under the skin in increasing doses, with the goal of seeing how safe it is when given in an outpatient clinic rather than a hospital. About 184 people will take part at sites across the United States. Doctors will track serious immune reactions and nerve problems, and also check how well the cancer responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epcoritamab, an experimental immunotherapy given as an injection under the skin
What this could lead to
If it works, this could offer a treatment option that patients can receive without staying in the hospital, making care easier for people with hard-to-treat lymphomas.
What could go wrong
This is a phase 2 safety trial, so researchers are still learning how well the drug works and how tolerable it is. Serious immune reactions and nerve side effects are possible, and the treatment may not help everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 184 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma neoplasm non-Hodgkin lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Classic follicular lymphoma Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • American Oncology Partners of Maryland /ID# 244968

    Bethesda, Maryland, 20817, United States

  • Auxilio Mutuo Cancer Center /ID# 254953

    San Juan, Puerto Rico, 00918, Puerto Rico

  • BRCR Medical Center Inc /ID# 262527

    Tamarac, Florida, 33321-2919, United States

  • Bennett Cancer Center - Stamford Hospital /ID# 244530

    Stamford, Connecticut, 06902-3602, United States

  • Beth Israel Deaconess Medical Center /ID# 248651

    Boston, Massachusetts, 02215-5400, United States

  • Beverly Hills Cancer Center /ID# 255327

    Beverly Hills, California, 90211, United States

  • Blue Ridge Cancer Center /ID# 260597

    Roanoke, Virginia, 24014-2419, United States

  • Cancer & Hematology Centers of Western Michigan - East /ID# 244985

    Grand Rapids, Michigan, 49546-7062, United States

  • Cancer Specialists of North Florida /ID# 261842

    Jacksonville, Florida, 32256, United States

  • Cleveland Clinic Florida /ID# 244532

    Weston, Florida, 33331-3609, United States

  • Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133

    Fountain Valley, California, 92708-7501, United States

  • Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003

    Lebanon, New Hampshire, 03756, United States

  • East Carolina University - Brody School of Medicine /ID# 248989

    Greenville, North Carolina, 27834, United States

  • Emory University, Winship Cancer Institute /ID# 246056

    Atlanta, Georgia, 30322, United States

  • Florida Cancer Specialists /ID# 260854

    Lake Mary, Florida, 32746-2115, United States

  • Hattiesburg Clinic /ID# 244980

    Hattiesburg, Mississippi, 39401, United States

  • Highlands Oncology Group, PA /ID# 245002

    Springdale, Arkansas, 72762, United States

  • Icahn School of Medicine at Mount Sinai /ID# 258610

    New York, New York, 10029, United States

  • Illinois Cancer Specialists /ID# 247655

    Niles, Illinois, 60714, United States

  • Indiana Blood & Marrow Transpl /ID# 244971

    Indianapolis, Indiana, 46237, United States

  • Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630

    Mobile, Alabama, 36607, United States

  • Lehigh Valley Hospital-Cedar Crest /ID# 244984

    Allentown, Pennsylvania, 18103-6202, United States

  • Maryland Oncology Hematology /ID# 254192

    Columbia, Maryland, 21044-3128, United States

  • Massachusetts General Hospital /ID# 245239

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center /ID# 246068

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Hospital West /ID# 248432

    Pembroke Pines, Florida, 33028, United States

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628

    New York, New York, 10065-6007, United States

  • Morristown Medical Center /ID# 244973

    Morristown, New Jersey, 07960-6136, United States

  • Mount Sinai Medical Center-Miami Beach /ID# 249045

    Miami Beach, Florida, 33140-2948, United States

  • NHO - Nebraska Hematology-Oncology /ID# 263164

    Lincoln, Nebraska, 68506, United States

  • New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681

    New Hyde Park, New York, 11042, United States

  • New York Cancer and Blood Specialists - Bronx /ID# 264690

    The Bronx, New York, 10469, United States

  • New York Cancer and Blood Specialists - New York /ID# 264676

    New York, New York, 10028, United States

  • New York Cancer and Blood Specialists /ID# 259016

    Port Jefferson Station, New York, 11776-8060, United States

  • Northwest Medical Specialties - Tacoma /ID# 245045

    Tacoma, Washington, 98405, United States

  • OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803

    Columbus, Ohio, 43214-3908, United States

  • Oncology Hematology Care, Inc. /ID# 246182

    Cincinnati, Ohio, 45236-2725, United States

  • Oregon Oncology Specialists in Salem /ID# 260570

    Salem, Oregon, 97301-3975, United States

  • Our Lady Of The Lake Regional Medical Center /ID# 255008

    Baton Rouge, Louisiana, 70808, United States

  • Pan American Center for Oncology Trials, LLC /ID# 254952

    Rio Piedras, Puerto Rico, 00935, Puerto Rico

  • Parkview Comprehensive Cancer Center /ID# 244545

    Fort Wayne, Indiana, 46845, United States

  • Penn State Milton S. Hershey Medical Center /ID# 244979

    Hershey, Pennsylvania, 17033-2360, United States

  • Prisma Health /ID# 247654

    Greenville, South Carolina, 29605, United States

  • Reading Hospital; McGlinn Cancer Institute /ID# 259181

    West Reading, Pennsylvania, 19611-2143, United States

  • Rocky Mountain Cancer Centers - Boulder /ID# 247653

    Boulder, Colorado, 80303, United States

  • Spoknwrd Clinical Trials /ID# 265232

    Easton, Pennsylvania, 18045, United States

  • St. Luke's Hospital - Chesterfield /ID# 247815

    Chesterfield, Missouri, 63017, United States

  • Stony Brook University Medical Center /ID# 244631

    New York, New York, 10021, United States

  • Texas Oncology - Austin Midtown /ID# 247656

    Austin, Texas, 78705, United States

  • Texas Oncology - Dallas - Worth Street /ID# 262956

    Dallas, Texas, 75246, United States

  • Texas Oncology - Northeast Texas /ID# 247657

    Tyler, Texas, 75702, United States

  • Texas Oncology - San Antonio Medical Center /ID# 247658

    San Antonio, Texas, 78240-5251, United States

  • Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659

    Dallas, Texas, 75231, United States

  • The John Theurer Cancer /ID# 262532

    Hackensack, New Jersey, 07601, United States

  • The West Clinic /ID# 245004

    Memphis, Tennessee, 38120, United States

  • Toledo Clinic Cancer Center - Main /ID# 246852

    Toledo, Ohio, 43623, United States

  • Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547

    Ypsilanti, Michigan, 48197-1051, United States

  • Tufts Medical Center /ID# 246074

    Boston, Massachusetts, 02111-1552, United States

  • UCSF Fresno /ID# 263286

    Fresno, California, 93701-2302, United States

  • UPMC Hillman Cancer Ctr /ID# 244571

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Arkansas for Medical Sciences /ID# 244562

    Little Rock, Arkansas, 72205, United States

  • University of California, Los Angeles /ID# 244573

    Los Angeles, California, 90095, United States

  • University of Illinois at Chicago /ID# 245038

    Chicago, Illinois, 60607, United States

  • University of Iowa Health Care /ID# 258227

    Des Moines, Iowa, 50314-3017, United States

  • University of New Mexico /ID# 252434

    Albuquerque, New Mexico, 87102-4517, United States

  • University of Oklahoma, Stephenson Cancer Center /ID# 244568

    Oklahoma City, Oklahoma, 73104-5418, United States

  • University of Texas Southwestern Medical Center /ID# 244552

    Dallas, Texas, 75390-7208, United States

  • Vanderbilt University Medical Center /ID# 260953

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists - Gainesville /ID# 248760

    Gainesville, Virginia, 20155-3257, United States

  • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514

    Norfolk, Virginia, 23502, United States

  • Wake Forest Univ HS /ID# 245005

    Winston-Salem, North Carolina, 27157, United States

  • Willamette Valley Cancer Institute and Research Center /ID# 246410

    Eugene, Oregon, 97401-6043, United States

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