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New antibody drug shows promise for Hard-to-Treat lymphoma

NCT ID NCT03625037

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This trial tests an antibody called epcoritamab in 666 people with B-cell lymphoma that has come back or not responded to treatment. The drug is designed to help the immune system attack cancer cells. The study looks at safety, the right dose, and how well the drug works.

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 antibody that helps the immune system attack cancer cells)
What this could lead to
If successful, this could provide a new treatment option for people with B-cell lymphoma that has not responded to other therapies.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or could cause significant side effects like cytokine release syndrome. Results may not apply to all lymphoma types.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

666 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Jan 2029

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.

Main Inclusion Criteria - Escalation Part (recruitment completed) * Documented CD20+ mature B-cell neoplasm 1. DLBCL - de novo or transformed 2. HGBCL 3. PMBCL 4. FL 5. MCL 6. SLL 7. MZL (nodal, extranodal or mucosa associated) * Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. * Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2. * Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan * Acceptable renal function. * Acceptable liver function. Main Inclusion Criteria - Expansion \& Dose-OPT Parts * Documented CD20 positive mature B cell neoplasm or CD20+ MCL. * DLBCL, de novo or transformed (including double hit or triple hit). * PMBCL * FL grade 3B * Histologic confirmed FL * MZL * SLL * MCL (prior Bruton's tyrosine kinase inhibitor \[BTKi\] or intolerant to BTKi) * At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen. * Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities. * At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes. Main Exclusion Criteria - All Parts * Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening. * Known past or current malignancy other than inclusion diagnosis. * Aspartate aminotransferase (AST), and/or alanine transaminase (ALT) \>3 × upper limit of normal. * Total bilirubin \>1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin. * Estimated Creatinine clearance (CrCl) \<45 milliliters (mL)/min. * Known clinically significant cardiovascular disease. * Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (COVID-19) infection may be a risk factor. * Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. * Seizure disorder requiring therapy (such as steroids or anti-epileptics). * Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20. * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration. * Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue. * Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation. * Active hepatitis B (deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\]-positive) or hepatitis C (ribonucleic acid \[RNA\] PCR-positive infection). Participants with evidence of prior hepatitis B (HBV) but who are PCR-negative are permitted in * Known human immunodeficiency virus (HIV) infection. * Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF). * Pregnancy or breast feeding. * Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant. * Contraindication to all uric acid lowering agents. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma indolent B-cell non-Hodgkin lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma primary mediastinal large B-cell lymphoma

As listed by the trial registrant

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

Aggressive B-cell non-Hodgkin lymphoma (ANHL) DLBCL FL High-grade B-cell lymphoma (HGBCL) Indolent B-cell non-Hodgkin lymphoma (INHL) Marginal zone lymphoma (MZL) MCL Primary mediastinal large B-cell lymphoma (PMBCL) Small lymphocytic lymphoma (SLL)

Contacts and locations

Locations

  • Akademiska sjukhuset Uppsala University Hospital

    Uppsala, Sweden

  • Ao Ss Antonio E Biagio Alessandria

    Alessandria, Italy

  • Arizona Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Asan Medical Center

    Seoul, South Korea

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48334, United States

  • CHU Montpellier

    Montpellier, France

  • CHU de Tours-Hopital Bretonneau

    Tours, France

  • Cabrini Hospital

    Malvern, Australia

  • Centre Henri Becquerel

    Rouen, France

  • Charite - Universitaetsmedizin Berlin

    Berlin, Germany

  • Chonbuk National University Hospital

    Jeonju, South Korea

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Concord Hospital

    Concord, Australia

  • Der Universität Munchen Medizinische Klinik III LMU

    München, Germany

  • Dong-A University Hospital

    Busan, South Korea

  • Erasmus MC Cancer Institute

    Rotterdam, Netherlands

  • Gold Coast Hospital

    Southport, Australia

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Helsinki University Hospital

    Helsinki, Finland

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Hopital Henri Mondor

    Créteil, France

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Hospital Germans Trias i Pujol

    Badalona, Spain

  • Hospital Saint-Louis

    Paris, France

  • Hospital Universitario Fundacin Jimnez Daz

    Madrid, Spain

  • Hospital Universitario Vall dHebron

    Barcelona, Spain

  • IRCCS Ospedale San Raffaele

    Milan, Italy

  • Institut Catala de Oncologia

    Barcelona, Spain

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Italy

  • Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

    Candiolo, Italy

  • Johannes Gutenberg University

    Mainz, Germany

  • Karolinska University Hospital Huddinge

    Stockholm, Sweden

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Klinik fur Innere Medizin Hamatologie and Onkologie

    Berlin, Germany

  • Kuopio University Hospital

    Kuopio, Finland

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Maastricht University Medical Center

    Maastricht, 6229 HX, Netherlands

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute

    Warsaw, Poland

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Monash Health

    Clayton, Australia

  • National Cancer Center

    Goyang-si, South Korea

  • National University Hospital

    Singapore, Singapore

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97210, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Odense University Hospital

    Odense, 5000 C, Denmark

  • Plymouth University School of Medicine- Derriford Hospital

    Plymouth, United Kingdom

  • Policlinico S. Orsola-Ematologia LA Seragnoli

    Bologna, Italy

  • Pratia-McM

    Krakow, Poland

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Rigshospitalet

    Copenhagen, Denmark

  • Royal Brisbane and Women's Hospital

    Herston, Australia

  • Royal Hobart Hospital RHH

    Hobart, Australia

  • Royal Marsden NHS Foundation Trust

    Sutton, United Kingdom

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University

    Seoul, South Korea

  • Singapore General Hospital

    Singapore, Singapore

  • Sir Charles Gairdner Hospital

    Nedlands, Australia

  • Skåne University Hospital

    Lund, Sweden

  • St. George Hospital

    Kogarah, Australia

  • St. Vincent Hospital

    Fitzroy, Australia

  • Szpital Uniwersytecki nr 2 im dr. Jana Biziela

    Bydgoszcz, Poland

  • Tampere University Hospital

    Tampere, Finland

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Tom Baker Cancer Care

    Calgary, Canada

  • Toronto-Sunnybrook Regional Cancer Ctr

    Toronto, Canada

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Essen

    Essen, Germany

  • Universitaetsklinikum Koeln

    Cologne, Germany

  • Universitair Medisch Centrum Utrecht

    Utrecht, Netherlands

  • University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • University of California at San Francisco

    San Francisco, California, 94117, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wroclaw, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • VU University Medical Center

    Amsterdam, Netherlands

  • Vejle Hospital

    Vejle, Denmark

  • Westmead Hospital

    Sydney, Australia

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

    Słupsk, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.