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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: 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)

In brief

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.

Key facts

Study ID

NCT03625037

Run by

Genmab

People needed

666

Starts

2018-06-26

Expected to finish

2029-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• OHSU Knight Cancer Institute — Portland, Oregon, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Southwestern — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Monash Health — Clayton, Australia
• Concord Hospital — Concord, Australia
• St. Vincent Hospital — Fitzroy, Australia
• Royal Brisbane and Women's Hospital — Herston, Australia
• Royal Hobart Hospital RHH — Hobart, Australia
• St. George Hospital — Kogarah, Australia
• Cabrini Hospital — Malvern, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• Arizona Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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