Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05206357 · ClinicalTrials.gov registry record · Phase 1
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 of Non-Hodgkin Lymphoma, sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 20
- Study locations
NCT05206357: Active Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Genmab.
NCT05206357 is a Phase 1 study of Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Genmab. The registered enrollment target is 17 participants, below the 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206357, a Phase 1 study of Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Epcoritamab
Study Locations (20)
Other
- Duplicate_Fakultni Nemocnice v Motole /ID# 239957 - Prague
- Hospices Civils de Lyon /ID# 240834 - Lyon
California
- Lucile Packard Children's Hospital /ID# 240854 - Palo Alto
Florida
- Nicklaus Children's Hospital /ID# 241174 - Miami
New York
- New York Medical College /ID# 239208 - Valhalla
North Carolina
- Levine Children's Hospital /ID# 242765 - Charlotte
Ohio
- Cincinnati Childrens Hospital Medical Center /ID# 239823 - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Main /ID# 239294 - Philadelphia
Tennessee
- St Jude Children's Research Hospital /ID# 239184 - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What the registry record for NCT05206357 still lists
NCT05206357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Epcoritamab is the first listed.
NCT05206357 names 20 study sites across 19 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05206357 about?
NCT05206357 is a clinical study titled "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". 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 pu...
What is the current status of trial NCT05206357?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-10-04. Estimated completion is 2028-11.
What conditions does trial NCT05206357 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05206357?
The interventions under investigation include: Epcoritamab (DRUG).
Who is sponsoring clinical trial NCT05206357?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206357 being conducted?
This trial has 20 study locations across California, Florida, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Hodgkin Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05206357's enrollment target sits among peer trials
17 94th of 106 higher than 13 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
RECRUITING · Phase 1
-
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
RECRUITING · Phase 1
-
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
RECRUITING · Phase 1
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
RECRUITING · Phase 1
-
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02090140 · 17 participants · NA
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- NCT03317860 · 17 participants · NA
Improving Measurement and Treatment of Post-stroke Neglect
- NCT04356469 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
- NCT04414046 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI