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NCT03625037 · ClinicalTrials.gov registry record · Phase 1
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
A Phase 1 study of DLBCL and Small Lymphocytic Lymphoma (SLL), sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 666
- Enrollment target
- 20
- Study locations
NCT03625037: Active Phase 1 study of DLBCL and Small Lymphocytic Lymphoma (SLL), sponsored by Genmab.
NCT03625037 is a Phase 1 study of DLBCL and Small Lymphocytic Lymphoma (SLL) that is active but no longer recruiting, run by Genmab. The registered enrollment target is 666 participants, above the 78-participant average among 14 other DLBCL trials with a reported enrollment target (754% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03625037, a Phase 1 study of DLBCL and Small Lymphocytic Lymphoma (SLL), is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 666 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the body does with epcoritamab once it is administered * What epcoritamab does to the body once it is administered * How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human \[FIH\]) * an expansion part (Phase 2a) * a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: * For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). * For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.
Primary Outcome
To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Conditions Studied
Interventions
- BIOLOGICAL Epcoritamab
Study Locations (20)
Other
- Monash Health - Clayton
- Concord Hospital - Concord
- St. Vincent Hospital - Fitzroy
Michigan
- University of Michigan - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
Texas
- UT Southwestern - Dallas
- MD Anderson Cancer Center - Houston
Arizona
- Arizona Mayo Clinic - Phoenix
California
- University of California at San Francisco - San Francisco
Colorado
- Colorado Blood Cancer Institute - Denver
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Iowa
- University of Iowa Hospital and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
What the registry record for NCT03625037 still lists
NCT03625037 is an interventional study that assigns participants to a tested intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 14 other DLBCL trials with a reported enrollment target (754% higher).
The record links to 9 conditions, with DLBCL appearing as the primary indexed condition, and to 1 intervention - of which Epcoritamab is the first listed.
NCT03625037 names 20 study sites across 16 states, led by Other, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT03625037 about?
NCT03625037 is a clinical study titled "First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma". The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the ...
What is the current status of trial NCT03625037?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 666 participants. The study started on 2018-06-26. Estimated completion is 2029-01.
What conditions does trial NCT03625037 study?
This clinical trial studies the following conditions: DLBCL, Small Lymphocytic Lymphoma (SLL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Marginal Zone Lymphoma (MZL), High Grade B-cell Lymphoma (HGBCL).
What interventions are being tested in trial NCT03625037?
The interventions under investigation include: Epcoritamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03625037?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03625037 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for DLBCL
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 NCT03625037's enrollment target sits among peer trials
666 1st of 14 higher than 14 of 14 other DLBCL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other DLBCL 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
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