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

Running, not enrolling · Phase 1

Conditions studied: Non-hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT05206357
Run by: Genmab
People needed: 17
Starts: 2022-10-04
Expected to finish: 2028-11-01
Last updated by the study team: 2025-04-08

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Lucile Packard Children's Hospital /ID# 240854 — Palo Alto, California, United States
Nicklaus Children's Hospital /ID# 241174 — Miami, Florida, United States
New York Medical College /ID# 239208 — Valhalla, New York, United States
Levine Children's Hospital /ID# 242765 — Charlotte, North Carolina, United States
Cincinnati Childrens Hospital Medical Center /ID# 239823 — Cincinnati, Ohio, United States
Children's Hospital of Philadelphia - Main /ID# 239294 — Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital /ID# 239184 — Memphis, Tennessee, United States
University of Texas Southwestern Medical Center /ID# 240892 — Dallas, Texas, United States
Children's Hospital at Westmead /ID# 240091 — Westmead, New South Wales, Australia
Royal Children's Hospital /ID# 240384 — Parkville, Victoria, Australia
Perth Children'S Hospital /ID# 240382 — Perth, Western Australia, Australia
Universitair Ziekenhuis Leuven /ID# 242384 — Leuven, Vlaams-Brabant, Belgium
Hospital for Sick Children /ID# 240767 — Toronto, Ontario, Canada
CHU Sainte-Justine /ID# 240766 — Montreal, Quebec, Canada
Fakultní Nemocnice Brno - Jihlavská /ID# 239956 — Brno, Brno-mesto, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 239957 — Prague, Czechia
CHU Bordeaux - Hopital Pellegrin /ID# 240832 — Bordeaux, New Aquitaine, France
CHU de Nantes, Hotel Dieu -HME /ID# 240831 — Nantes, Pays de la Loire Region, France
Institut Gustave Roussy /ID# 240966 — Villejuif, Val-de-Marne, France
Hospices Civils de Lyon /ID# 240834 — Lyon, France
Universitaetsklinikum Erlangen /ID# 240861 — Erlangen, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg /ID# 240787 — Marburg, Hesse, Germany
Universitaetsklinikum Muenster /ID# 239970 — Münster, North Rhine-Westphalia, Germany
Schneider Children's Medical Center /ID# 240171 — Petah Tikva, Central District, Israel
Rambam Health Care Campus /ID# 240037 — Haifa, H_efa, Israel

Full record on ClinicalTrials.gov

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