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New drug combo shows promise against blood cancer

NCT ID NCT04663347

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This study tests a drug called epcoritamab, alone or with other treatments, in people with B-cell non-Hodgkin lymphoma, a type of blood cancer. The goal is to find the best dose and see how well it works. About 543 participants will receive the drug under the skin or through an IV. The study is active but not currently recruiting.

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

543 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Sep 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.

Key Inclusion Criteria 1. Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7. 2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2 3. Acceptable organ function at screening 4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy 5. If of childbearing potential participant must practicing a highly effective method of birth control 6. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control Arm 1: * Newly diagnosed DLBCL * DLBCL, not otherwise specified (NOS) * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 2: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4: * Documented R/R DLBCL and eligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 5: * Documented R/R DLBCL and ineligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 6: Newly diagnosed, previously untreated FL grade 1-3A Arm 7: * FL Grade 1-3A * If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment. Arm 8: * Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline * T-cell/histiocyte rich DLBCL * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 9: * R/R FL * Progressed within 24 months of initiating first-line treatment Arm 10: * Documented R/R DLBCL and eligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Key Exclusion Criteria 1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab 2. Any prior treatment with a bispecific antibody targeting CD3 and CD20. 3. Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab 4. Clinically significant cardiovascular disease 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results 6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture 7. Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection 8. Known history of seropositivity of human immunodeficiency virus (HIV) 9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months 10. Neuropathy \> grade 1 11. Receiving immunostimulatory agent 12. Prior allogeneic HSCT 13. Current seizure disorder requiring anti-epileptic therapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma Follicular lymphoma

Contacts and locations

Locations

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Akademiska Sjukhuset

    Uppsala, Sweden

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1105 AZ, Netherlands

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, 42123, Italy

  • Austin Health

    Heidelberg, VIC 3084, Australia

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127, Italy

  • CHU UCL Namur Site Godinne

    Yvoir, 5530, Belgium

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, Czechia

  • Fakultni nemocnice v Motole

    Prague, 15006, Czechia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS

    Candiolo, 10060, Italy

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7D, United Kingdom

  • HUS Cancer Center

    Lahti, 15850, Finland

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hopital Claude Huriez - CHRU Lille

    Lille, 59037, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hôpital Saint-Louis

    Paris, 75475, France

  • Hôpital de la Timone

    Marseille, 13005, France

  • ICO l Hospitalet

    Barcelona, 08908, Spain

  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

    Meldola, 47014, Italy

  • Karolinska Universitetssjukhuset

    Solna, Sweden

  • Kuopio University Hospital

    Kuopio, 70210, Finland

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Levine Cancer Center

    Charlotte, North Carolina, 28204, United States

  • Linear Clinical Research Limited

    Nedlands, 6009, Australia

  • Maastricht University Medical Center

    Maastricht, 6229 HX, Netherlands

  • Memorial Sloan Kettering CC

    New York, New York, 10065, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Odense University Hospital

    Odense, Denmark

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 310, Norway

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Sahlgrenska Sjukhuset

    Gothenburg, 413 45, Sweden

  • Skånes Universitetssjukhus

    Lund, Sweden

  • Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Södra Älvsborgs Sjukhus

    Borås, Sweden

  • The Christie Hospital

    Manchester, United Kingdom

  • UMC Utrecht

    Utrecht, 3584, Netherlands

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Vejle Sygehus

    Vejle, Denmark

  • Vseobecna Fakultni Nemocnice

    Prague, Czechia

  • Århus Hospital

    Aarhus, Denmark

More trials for these conditions

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