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First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2026-05-05

No results posted yet for this 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

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

Interventions

BIOLOGICAL

Epcoritamab

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625037 on ClinicalTrials.gov