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

NCT05206357 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: M20-4292021-004555-16
• Study Type: interventional
• Target: 17
• Locations: 14 countries
• Sites: 41

Brief 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. 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.

Conditions

Non-hodgkin Lymphoma

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Percentage of Participants who Achieve Complete Response (CR)

  Up to Approximately 1 Year

• Number of Participants with Event-free survival (EFS)

  Up to Approximately 3 Years

• Number of Participants who Achieve Overall Survival (OS)

  Up to Approximately 3 Years

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

  Up to Approximately 1 Year

• Percentage of Participants Achieving Overall Response (OR)

  Up to Approximately 1 Year

Study Arms (1)

Epcoritamab

EXPERIMENTAL

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Drug: Epcoritamab

Interventions

Epcoritamab DRUG

Subcutaneous Injection (SC)

Also known as: ABBV-GMAB-3013

Epcoritamab

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead
• AbbVie: collaborator

Study Sites (41)

Lucile Packard Children's Hospital /ID# 240854

Palo Alto, California, 94304, United States

Location

Nicklaus Children's Hospital /ID# 241174

Miami, Florida, 33155-3009, United States

Location

New York Medical College /ID# 239208

Valhalla, New York, 10595, United States

Location

Levine Children's Hospital /ID# 242765

Charlotte, North Carolina, 28203, United States

Location

Cincinnati Childrens Hospital Medical Center /ID# 239823

Cincinnati, Ohio, 45229, United States

Location

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

Philadelphia, Pennsylvania, 19104-4319, United States

Location

St Jude Children's Research Hospital /ID# 239184

Memphis, Tennessee, 38105, United States

Location

University of Texas Southwestern Medical Center /ID# 240892

Dallas, Texas, 75390-7208, United States

Location

Children's Hospital at Westmead /ID# 240091

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital /ID# 240384

Parkville, Victoria, 3052, Australia

Location

Perth Children'S Hospital /ID# 240382

Perth, Western Australia, 6009, Australia

Location

Universitair Ziekenhuis Leuven /ID# 242384

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Hospital for Sick Children /ID# 240767

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte-Justine /ID# 240766

Montreal, Quebec, H3T 1C5, Canada

Location

Fakultní Nemocnice Brno - Jihlavská /ID# 239956

Brno, Brno-mesto, 625 00, Czechia

Location

Duplicate_Fakultni Nemocnice v Motole /ID# 239957

Prague, 150 00, Czechia

Location

CHU Bordeaux - Hopital Pellegrin /ID# 240832

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

Institut Gustave Roussy /ID# 240966

Villejuif, Val-de-Marne, 94805, France

Location

Hospices Civils de Lyon /ID# 240834

Lyon, 69003, France

Location

Universitaetsklinikum Erlangen /ID# 240861

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Giessen und Marburg /ID# 240787

Marburg, Hesse, 35043, Germany

Location

Universitaetsklinikum Muenster /ID# 239970

Münster, North Rhine-Westphalia, 48149, Germany

Location

Schneider Children's Medical Center /ID# 240171

Petah Tikva, Central District, 4920235, Israel

Location

Rambam Health Care Campus /ID# 240037

Haifa, H_efa, 3109601, Israel

Location

The Chaim Sheba Medical Center /ID# 240670

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Azienda Ospedaliero Universitaria Meyer /ID# 240049

Florence, Firenze, 50139, Italy

Location

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

Monza, Monza E Brianza, 20052, Italy

Location

Ospedale Pediatrico Bambino Gesù /ID# 240039

Rome, Roma, 00165, Italy

Location

NHO Nagoya Medical Center /ID# 246680

Nagoya, Aichi-ken, 460-0001, Japan

Location

Kyoto University Hospital /ID# 246907

Kyoto, Kyoto, 606-8507, Japan

Location

Osaka City General Hospital /ID# 246906

Osaka, Osaka, 534-0021, Japan

Location

National Cancer Center Hospital /ID# 246722

Chuo-ku, Tokyo, 104-0045, Japan

Location

National Center for Child Health and Development /ID# 246658

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Seoul National University Hospital /ID# 239894

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 239895

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Hospital Sant Joan de Deu /ID# 240719

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 240715

Barcelona, 08035, Spain

Location

Hospital Infantil Universitario Nino Jesus /ID# 240717

Madrid, 28009, Spain

Location

National Taiwan University Hospital /ID# 242890

Taipei City, Taipei, 100, Taiwan

Location

Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: January 25, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); TW (1); CZ (2); US (8); DE (3); TU (1); JP (5); BE (1); FR (4); IT (3); KR (2); IL (3); ES (3); AU (3)