Cure My Disease

Don't miss your cure!

 Log in / Sign up

Immunotherapy injection tested against Hard-to-Treat childhood lymphoma

NCT ID NCT05206357

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Standard treatment cures most children with aggressive mature B-cell lymphomas, but those whose cancer returns or resists therapy have few options. This phase 1b trial tests epcoritamab, an experimental immunotherapy given as an injection under the skin, in children and young adults up to age 25 with relapsed or refractory Burkitt lymphoma, diffuse large B-cell lymphoma, or similar cancers. Researchers will track side effects, drug levels in the body, and whether the cancer shrinks. Participants receive the drug in 28-day cycles and are followed for at least three years.

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, epcoritamab could offer a new treatment option for children and young adults whose aggressive B-cell lymphoma has come back or stopped responding to standard therapy.
What could go wrong
This is a small, early-stage trial focused first on safety, so researchers do not yet know whether the drug helps. Children may face more clinic visits and side effects than with standard care.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Nov 2028

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

1 year to 25 years

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: * Participants \>= 1 and \< 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible. * Disease pathologically confirmed (tumor tissue) by local testing. * Relapsed or primary refractory disease meeting any of the following criteria: * Progressive disease at any time during second-line chemoimmunotherapy (CIT). * Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT. * Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT. * Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy. * Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT. * Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR. * Recovery from toxic effects of prior chemoimmunotherapy. * Performance status by Lansky (\< 16 years old at evaluation) or Karnofsky (\>= 16 years old at evaluation) score \>= 50 or Eastern Cooperative Oncology Group (ECOG) score \<= 2 . * Adequate bone marrow, hepatic, and renal function. Exclusion Criteria: * Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible). * Other malignancy requiring therapy. * Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Non-Hodgkin lymphoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

B-cell neoplasm diffuse large B-cell lymphoma leukemia neoplasm non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

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

Non-Hodgkin lymphoma

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Meyer /ID# 240049

    Florence, Firenze, 50139, Italy

  • CHU Bordeaux - Hopital Pellegrin /ID# 240832

    Bordeaux, New Aquitaine, 33076, France

  • CHU Sainte-Justine /ID# 240766

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de Nantes, Hotel Dieu -HME /ID# 240831

    Nantes, Pays de la Loire Region, 44000, France

  • Children's Hospital at Westmead /ID# 240091

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Philadelphia - Main /ID# 239294

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Cincinnati Childrens Hospital Medical Center /ID# 239823

    Cincinnati, Ohio, 45229, United States

  • Duplicate_Fakultni Nemocnice v Motole /ID# 239957

    Prague, 150 00, Czechia

  • Fakultní Nemocnice Brno - Jihlavská /ID# 239956

    Brno, Brno-mesto, 625 00, Czechia

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 245592

    Monza, Monza E Brianza, 20052, Italy

  • Hospices Civils de Lyon /ID# 240834

    Lyon, 69003, France

  • Hospital Infantil Universitario Nino Jesus /ID# 240717

    Madrid, Madrid, 28009, Spain

  • Hospital Sant Joan de Deu /ID# 240719

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario Vall d'Hebron /ID# 240715

    Barcelona, Barcelona, 08035, Spain

  • Hospital for Sick Children /ID# 240767

    Toronto, Ontario, M5G 1X8, Canada

  • Institut Gustave Roussy /ID# 240966

    Villejuif, Val-de-Marne, 94805, France

  • Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026

    Istanbul, 34010, Turkey (Türkiye)

  • Kyoto University Hospital /ID# 246907

    Kyoto, Kyoto, 606-8507, Japan

  • Levine Children's Hospital /ID# 242765

    Charlotte, North Carolina, 28203, United States

  • Lucile Packard Children's Hospital /ID# 240854

    Palo Alto, California, 94304, United States

  • NHO Nagoya Medical Center /ID# 246680

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Cancer Center Hospital /ID# 246722

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Center for Child Health and Development /ID# 246658

    Setagaya-ku, Tokyo, 157-8535, Japan

  • National Taiwan University Hospital /ID# 242890

    Taipei City, Taipei, 100, Taiwan

  • New York Medical College /ID# 239208

    Valhalla, New York, 10595, United States

  • Nicklaus Children's Hospital /ID# 241174

    Miami, Florida, 33155-3009, United States

  • Osaka City General Hospital /ID# 246906

    Osaka, Osaka, 534-0021, Japan

  • Ospedale Pediatrico Bambino Gesù /ID# 240039

    Rome, Roma, 00165, Italy

  • Perth Children'S Hospital /ID# 240382

    Perth, Western Australia, 6009, Australia

  • Rambam Health Care Campus /ID# 240037

    Haifa, H_efa, 3109601, Israel

  • Royal Children's Hospital /ID# 240384

    Parkville, Victoria, 3052, Australia

  • Samsung Medical Center /ID# 239895

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Schneider Children's Medical Center /ID# 240171

    Petah Tikva, Central District, 4920235, Israel

  • Seoul National University Hospital /ID# 239894

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • St Jude Children's Research Hospital /ID# 239184

    Memphis, Tennessee, 38105, United States

  • The Chaim Sheba Medical Center /ID# 240670

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Universitaetsklinikum Erlangen /ID# 240861

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Giessen und Marburg /ID# 240787

    Marburg, Hesse, 35043, Germany

  • Universitaetsklinikum Muenster /ID# 239970

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitair Ziekenhuis Leuven /ID# 242384

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Texas Southwestern Medical Center /ID# 240892

    Dallas, Texas, 75390-7208, United States

More trials for these conditions

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