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)
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Lucile Packard Children's Hospital /ID# 240854 — Palo Alto, California
Age range: 1 Year to 25 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- Lucile Packard Children's Hospital /ID# 240854 — Palo Alto, California
- Nicklaus Children's Hospital /ID# 241174 — Miami, Florida
- New York Medical College /ID# 239208 — Valhalla, New York
- Levine Children's Hospital /ID# 242765 — Charlotte, North Carolina
- Cincinnati Childrens Hospital Medical Center /ID# 239823 — Cincinnati, Ohio
- Children's Hospital of Philadelphia - Main /ID# 239294 — Philadelphia, Pennsylvania
- St Jude Children's Research Hospital /ID# 239184 — Memphis, Tennessee
- University of Texas Southwestern Medical Center /ID# 240892 — Dallas, Texas
- Children's Hospital at Westmead /ID# 240091 — Westmead, New South Wales
- Royal Children's Hospital /ID# 240384 — Parkville, Victoria
- Perth Children'S Hospital /ID# 240382 — Perth, Western Australia
- Universitair Ziekenhuis Leuven /ID# 242384 — Leuven, Vlaams-Brabant
- Hospital for Sick Children /ID# 240767 — Toronto, Ontario
- CHU Sainte-Justine /ID# 240766 — Montreal, Quebec
- Fakultní Nemocnice Brno - Jihlavská /ID# 239956 — Brno, Brno-mesto
- Duplicate_Fakultni Nemocnice v Motole /ID# 239957 — Prague,
- CHU Bordeaux - Hopital Pellegrin /ID# 240832 — Bordeaux, New Aquitaine
- CHU de Nantes, Hotel Dieu -HME /ID# 240831 — Nantes, Pays de la Loire Region
- Institut Gustave Roussy /ID# 240966 — Villejuif, Val-de-Marne
- Hospices Civils de Lyon /ID# 240834 — Lyon,
- Universitaetsklinikum Erlangen /ID# 240861 — Erlangen, Bavaria
- Universitaetsklinikum Giessen und Marburg /ID# 240787 — Marburg, Hesse
- Universitaetsklinikum Muenster /ID# 239970 — Münster, North Rhine-Westphalia
- Schneider Children's Medical Center /ID# 240171 — Petah Tikva, Central District
- Rambam Health Care Campus /ID# 240037 — Haifa, H_efa
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.