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 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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-hodgkin Lymphoma
• Intervention / Treatment: Drug: Epcoritamab

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Children's Hospital at Westmead /ID# 240091
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital /ID# 240384
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Perth Children'S Hospital /ID# 240382
• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 242384
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children /ID# 240767
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine /ID# 240766
• Czechia
  • Prague, Czechia, 150 00
    • Duplicate_Fakultni Nemocnice v Motole /ID# 239957
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní Nemocnice Brno - Jihlavská /ID# 239956
• France
  • Lyon, France, 69003
    • Hospices Civils de Lyon /ID# 240834
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33076
      • CHU Bordeaux - Hopital Pellegrin /ID# 240832
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 240831
  • Val-de-Marne
    • Villejuif Cedex, Val-de-Marne, France, 94805
      • Institut Gustave Roussy /ID# 240966
• Germany
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 240861
  • Hessen
    • Marburg, Hessen, Germany, 35043
      • Universitaetsklinikum Giessen und Marburg /ID# 240787
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 239970
• Israel
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 240037
  • HaMerkaz
    • Petah Tikva, HaMerkaz, Israel, 4920235
      • Schneider Children's Medical Center /ID# 240171
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 240670
• Italy
  • Firenze
    • Florence, Firenze, Italy, 50139
      • Azienda Ospedaliero Universitaria Meyer /ID# 240049
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20052
      • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 245592
  • Roma
    • Rome, Roma, Italy, 00165
      • Ospedale Pediatrico Bambino Gesù /ID# 240039
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 460-0001
      • NHO Nagoya Medical Center /ID# 246680
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 246907
  • Osaka
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 246906
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 246722
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • National Center for Child Health and Development /ID# 246658
• Korea, Republic of
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital /ID# 239894
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 239895
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 240715
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus /ID# 240717
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu /ID# 240719
• Taiwan
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 242890
• Turkey
  • Istanbul, Turkey, 34010
    • Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital /ID# 240854
  • Florida
    • Miami, Florida, United States, 33155-3009
      • Nicklaus Children's Hospital /ID# 241174
  • New York
    • Valhalla, New York, United States, 10595
      • New York Medical College /ID# 239208
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Levine Children's Hospital /ID# 242765
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center /ID# 239823
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Children's Hospital of Philadelphia - Main /ID# 239294
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St Jude Children's Research Hospital /ID# 239184
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • University of Texas Southwestern Medical Center /ID# 240892

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab; Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.	Drug: Epcoritamab; Subcutaneous Injection (SC); Other Names: ABBV-GMAB-3013

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Approximately 3 Years
Maximum Observed Concentration (Cmax)	Maximum observed concentration.	Up to Approximately Week 37
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.	Up to Approximately Week 37

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to Approximately 1 Year
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.	Up to Approximately 3 Years
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.	Up to Approximately 3 Years
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.	Up to Approximately 1 Year
Percentage of Participants Achieving Overall Response (OR)	OR is assessed as the percentage of participants with an overall response.	Up to Approximately 1 Year
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.	Up to Approximately 1 Year
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.	Up to Approximately 1 Year
Percentage of Participants Achieving Immunogenicity	Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).	Up to Approximately Week 37

Collaborators and Investigators

• Sponsor: Genmab
• Collaborators: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Diffuse Large B-cell Lymphoma; Epcoritamab; ABBV-GMAB-3013; Burkitt's or Burkitt-like Lymphoma/Leukemia; Aggressive Mature (CD20+) B-cell Lymphoma; Relapsed/Refractory Aggressive Mature B-cell Neoplasms; Non-hodgkin Lymphoma; EPCORE
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Immune System Diseases; Behavioral Symptoms; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Aggression
• Other Study ID Numbers: M20-429; 2021-004555-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No