Active not recruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is looking at a new drug, epcoritamab (also known as EPKINLY™), for adults with specific types of B-cell lymphoma that haven't responded well to other treatments or have returned. The main goals are to find the best dose, understand any side effects, and see how effective it is in treating these lymphomas. The study is divided into different parts, with each participant receiving the active drug. No one in this study will receive a dummy treatment (placebo). Participation involves regular hospital visits over roughly 1 to 1.5 years, including screening, treatment, and follow-up periods. It's a 'first-in-human' study, meaning it's one of the first times this drug is being used in people.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Genmab

Enrolment target

666

Start

26 Jun 2018

Estimated completion

01 Jan 2029

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)

What is this study about?

This study is a medical research project focused on a new medicine called epcoritamab, also known as EPKINLY™. It's being tested in adults who have certain types of B-cell lymphoma. These are cancers that affect a type of white blood cell called B-cells. The study is specifically for people whose lymphoma has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

The main aim of this study is to learn more about epcoritamab. Researchers want to figure out the best dose to give, understand any side effects it might cause, and see how the body handles the drug and what effects the drug has on the body and the lymphoma. Essentially, they want to understand how safe and effective this new medicine is. The study is being conducted in different stages. In the early stages, called Phase 1, the focus is on finding the safest and most effective dose. Later stages, called Phase 2, look at how well the drug works in more people and continue to gather information on its safety.

It's important to know that everyone taking part in this study will receive the active drug, epcoritamab. No one will be given a placebo, which is a dummy treatment. This approach helps researchers gather consistent information about the new medicine. The study includes different types of B-cell lymphoma, such as Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), and Mantle Cell Lymphoma (MCL), among others. This research is a crucial step in developing new treatments for these challenging forms of lymphoma.

Key takeaways

This study is testing a new drug, epcoritamab, for B-cell lymphoma that has relapsed or not responded to other treatments.
The main goals are to find the best dose, understand side effects, and see how well it works.
All participants will receive the active study drug; no one will get a placebo.
Participation involves regular hospital visits over 1 to 1.5 years.
It's for adults 18 and over with specific types of B-cell lymphoma.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults, 18 years and older, who have been diagnosed with certain types of B-cell lymphoma. These include specific forms like Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and others. A key requirement is that your lymphoma must have either returned after previous treatments or not responded to them, especially after treatments that included an anti-CD20 medicine like rituximab, or after a stem cell transplant.

To be considered, you'll need to be in generally good health, as assessed by your doctor, and have healthy kidney and liver function. Your lymphoma also needs to be measurable, meaning doctors can see and track it using scans like CT, MRI, or PET-CT. You cannot join if your lymphoma is in your brain or spinal cord, or if you've had another cancer recently (other than the lymphoma being studied).

There are also specific criteria depending on which part of the study you might join. For example, if you have Mantle Cell Lymphoma, you would typically have had a specific previous treatment for it. The research team will carefully review all your medical information to see if this study is suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have a B-cell lymphoma that has come back or not responded to previous treatments?
Have you previously been treated with an anti-CD20 drug (like rituximab)?
Are your doctors able to measure your lymphoma on scans (CT, MRI, or PET-CT)?
Is your general health, kidney, and liver function considered good by your doctor?
Is your lymphoma NOT in your brain or spinal cord?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it will involve regular visits to the hospital or clinic. Initially, especially in the first month, these visits might be quite frequent – daily or every few days. After that, the visits will become less frequent, perhaps weekly, every other week, or once a month, gradually spacing out as your time in the study progresses.

The overall length of time you'll be in the study varies. If you join the early part of the study (called the 'dose-escalation part'), you'll be involved for about a year. This includes up to 21 days for initial checks and tests (screening), about 6 months of receiving the study drug, and then 6 months of follow-up after your treatment ends. If you join the later parts of the study (the 'expansion' or 'dose-optimization' parts), your participation will be for about 1.5 years, which also includes screening, about 1 year of receiving the study drug, and then 6 months of follow-up.

During your visits, you'll have various tests and procedures to check your health, understand any side effects, and see how the drug is working. Remember, everyone in this study receives the active study drug, epcoritamab; no one will be given a placebo.

Potential risks and benefits

Participating in a study like this can offer the potential benefit of accessing a new treatment (epcoritamab) for your lymphoma that may not be available otherwise, especially if standard treatments haven't worked or your lymphoma has returned. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known or understood. The study aims to identify and manage these side effects. Your safety is a top priority, and you'll be closely monitored by medical staff throughout your participation. It's very important to remember that joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (85)

Arizona Mayo Clinic
Phoenix, United States
University of California at San Francisco
San Francisco, United States
Colorado Blood Cancer Institute
Denver, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United States
University of Iowa Hospital and Clinics
Iowa City, United States
Ochsner Medical Center
New Orleans, United States
University of Michigan
Ann Arbor, United States
Barbara Ann Karmanos Cancer Institute
Detroit, United States
University of Nebraska Medical Center
Omaha, United States
Hackensack Meridian Health
Hackensack, United States
The Cleveland Clinic Foundation
Cleveland, United States
OHSU Knight Cancer Institute
Portland, United States

+73 more sites — see the official record for the full list.

Common questions

What is B-cell lymphoma?

B-cell lymphoma is a type of cancer that starts in white blood cells called B-cells, which are part of your immune system.

What is epcoritamab?

Epcoritamab, also known as EPKINLY™, is an experimental new medicine being tested to treat certain types of B-cell lymphoma.

Will I get a dummy treatment (placebo) in this study?

No, everyone who joins this study will receive the active study medicine, epcoritamab.

How long will I need to be in the study?

Your participation could last between 1 to 1.5 years, which includes screening, receiving treatment, and follow-up checks.

What kind of visits will I have?

You'll have regular visits to the hospital or clinic, which will be more frequent at the beginning and then become less often over time.