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AzTrials

Non-hodgkin LymphomaPhase 1NCT05206357

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

A Phase 1 study testing Epcoritamab in people with Non-hodgkin Lymphoma, run by Genmab at 41 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. Read more about this study

Who is it for?
Ages 1 year to 25 years
Conditions the study is for
Non-hodgkin Lymphoma
What is being tested?
Epcoritamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
41 sitesin 14 countries
Study dates
4 Oct 2022to Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

41 sites in 14 countries.

41 sites in 14 countries

United States8 sites

  • Levine Children's Hospital /ID# 242765

    Charlotte, North Carolina, 28203

  • Cincinnati Childrens Hospital Medical Center /ID# 239823

    Cincinnati, Ohio, 45229

  • University of Texas Southwestern Medical Center /ID# 240892

    Dallas, Texas, 75390-7208

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

    Memphis, Tennessee, 38105

  • Nicklaus Children's Hospital /ID# 241174

    Miami, Florida, 33155-3009

  • Lucile Packard Children's Hospital /ID# 240854

    Palo Alto, California, 94304

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

    Philadelphia, Pennsylvania, 19104-4319

  • New York Medical College /ID# 239208

    Valhalla, New York, 10595

Other trials in United States

Japan5 sites

  • National Cancer Center Hospital /ID# 246722

    Chuo-ku, Tokyo, 104-0045

  • Kyoto University Hospital /ID# 246907

    Kyoto, Kyoto, 606-8507

  • NHO Nagoya Medical Center /ID# 246680

    Nagoya, Aichi-ken, 460-0001

  • Osaka City General Hospital /ID# 246906

    Osaka, Osaka, 534-0021

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

    Setagaya-ku, Tokyo, 157-8535

Other trials in Japan

France4 sites

  • CHU Bordeaux - Hopital Pellegrin /ID# 240832

    Bordeaux, New Aquitaine, 33076

  • Hospices Civils de Lyon /ID# 240834

    Lyon, 69003

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

    Nantes, Pays de la Loire Region, 44000

  • Institut Gustave Roussy /ID# 240966

    Villejuif, Val-de-Marne, 94805

Other trials in France

Australia3 sites

  • Royal Children's Hospital /ID# 240384

    Parkville, Victoria, 3052

  • Perth Children'S Hospital /ID# 240382

    Perth, Western Australia, 6009

  • Children's Hospital at Westmead /ID# 240091

    Westmead, New South Wales, 2145

Other trials in Australia

Germany3 sites

  • Universitaetsklinikum Erlangen /ID# 240861

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Giessen und Marburg /ID# 240787

    Marburg, Hesse, 35043

  • Universitaetsklinikum Muenster /ID# 239970

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Israel3 sites

  • Rambam Health Care Campus /ID# 240037

    Haifa, H_efa, 3109601

  • Schneider Children's Medical Center /ID# 240171

    Petah Tikva, Central District, 4920235

  • The Chaim Sheba Medical Center /ID# 240670

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Italy3 sites

  • Azienda Ospedaliero Universitaria Meyer /ID# 240049

    Florence, Firenze, 50139

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

    Monza, Monza E Brianza, 20052

  • Ospedale Pediatrico Bambino Gesù /ID# 240039

    Rome, Roma, 00165

Other trials in Italy

Spain3 sites

  • Hospital Universitario Vall d'Hebron /ID# 240715

    Barcelona, Barcelona, 08035

  • Hospital Sant Joan de Deu /ID# 240719

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Infantil Universitario Nino Jesus /ID# 240717

    Madrid, Madrid, 28009

Other trials in Spain

Canada2 sites

  • CHU Sainte-Justine /ID# 240766

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children /ID# 240767

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Czechia2 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 239956

    Brno, Brno-mesto, 625 00

  • Duplicate_Fakultni Nemocnice v Motole /ID# 239957

    Prague, 150 00

Other trials in Czechia

South Korea2 sites

  • Seoul National University Hospital /ID# 239894

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 239895

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Belgium1 site

  • Universitair Ziekenhuis Leuven /ID# 242384

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Taiwan1 site

  • National Taiwan University Hospital /ID# 242890

    Taipei City, Taipei, 100

Other trials in Taiwan

Turkey (Türkiye)1 site

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

    Istanbul, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.

Read more

Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.

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.

Being tested
Epcoritamab
Keywords
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms, EPCORE
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabDrug

    Also called ABBV-GMAB-3013

    Subcutaneous Injection (SC)

Study groups in NCT05206357
Study groupRoleWhat they receive
EpcoritamabExperimentalParticipants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AE)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 3 Years

  2. Maximum Observed Concentration (Cmax)

    Maximum observed concentration.

    Measured: Up to Approximately Week 37

  3. Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)

    AUC from time 0 to time of last measurable concentration within the dosing interval.

    Measured: Up to Approximately Week 37

Secondary outcomes (8)

  1. Percentage of Participants who Achieve Complete Response (CR)

    CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).

    Measured: Up to Approximately 1 Year

  2. Number of Participants with Event-free survival (EFS)

    EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.

    Measured: Up to Approximately 3 Years

  3. Number of Participants who Achieve Overall Survival (OS)

    OS will be defined as the number of days from screening to the date of death from any cause.

    Measured: Up to Approximately 3 Years

  4. Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy

    Rate of initiation of stem cell transplantation or CAR-T therapy.

    Measured: Up to Approximately 1 Year

  5. Percentage of Participants Achieving Overall Response (OR)

    OR is assessed as the percentage of participants with an overall response.

    Measured: Up to Approximately 1 Year

  6. Duration of response (DOR)

    DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.

    Measured: Up to Approximately 1 Year

  7. Duration of CR (DOCR)

    DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.

    Measured: Up to Approximately 1 Year

  8. Percentage of Participants Achieving Immunogenicity

    Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).

    Measured: Up to Approximately Week 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start4 Oct 2022
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05206357
Sponsor's protocol ID
M20-429
Other IDs
2021-004555-16
Status last verified
Sep 2026
First submitted
21 Jan 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epcoritamab in people with Non-hodgkin Lymphoma, run by Genmab at 41 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Japan, France, Australia, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AE) (time frame: Up to Approximately 3 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05206357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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