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A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma
NCT05451810 · View on ClinicalTrials.gov ↗
Study Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. 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 Studied
Interventions
- DRUG Epcoritamab
Study Locations (20)
Florida
- Cancer Specialists of North Florida /ID# 261842 — Jacksonville
- Florida Cancer Specialists /ID# 260854 — Lake Mary
- Mount Sinai Medical Center-Miami Beach /ID# 249045 — Miami Beach
- Memorial Hospital West /ID# 248432 — Pembroke Pines
- BRCR Medical Center Inc /ID# 262527 — Tamarac
- Cleveland Clinic Florida /ID# 244532 — Weston
California
- Beverly Hills Cancer Center /ID# 255327 — Beverly Hills
- Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 — Fountain Valley
- UCSF Fresno /ID# 263286 — Fresno
- University of California, Los Angeles /ID# 244573 — Los Angeles
Arkansas
- University of Arkansas for Medical Sciences /ID# 244562 — Little Rock
- Highlands Oncology Group, PA /ID# 245002 — Springdale
Illinois
- University of Illinois at Chicago /ID# 245038 — Chicago
- Illinois Cancer Specialists /ID# 247655 — Niles
Alabama
- Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 — Mobile
Colorado
- Rocky Mountain Cancer Centers - Boulder /ID# 247653 — Boulder
Connecticut
- Bennett Cancer Center - Stamford Hospital /ID# 244530 — Stamford
District of Columbia
- MedStar Washington Hospital Center /ID# 246068 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05451810
The ClinicalTrials.gov registry entry for NCT05451810 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which Epcoritamab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05451810 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05451810 about?
NCT05451810 is a clinical study titled "A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in r...
What is the current status of trial NCT05451810?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2022-08-17. Estimated completion is 2027-03.
What conditions does trial NCT05451810 study?
This clinical trial studies the following conditions: Diffuse Large B-Cell Lymphoma, Classic Follicular Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05451810?
The interventions under investigation include: Epcoritamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05451810?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05451810 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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