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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 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.

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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.

Conditions Studied

DLBCL Small Lymphocytic Lymphoma (SLL) Primary Mediastinal Large B-cell Lymphoma (PMBCL) Marginal Zone Lymphoma (MZL) High Grade B-cell Lymphoma (HGBCL) MCL FL Indolent B-cell Non-Hodgkin Lymphoma (iNHL) Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)

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

FieldValue
Enrollment Target 666 participants
Start Date 2018-06-26
Est. Completion 2029-01
Phase Phase 1

Sponsor

Genmab

45 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03625037

The ClinicalTrials.gov registry entry for NCT03625037 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 14 other DLBCL trials with a reported enrollment target (754% higher). The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.