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Monoclonal Antibodies

Epcoritamab for B-Cell Lymphoma (EPCORE™ NHL-1 Trial)

Phase 1 & 2

Waitlist Available

Led By Pieternella Lugtenburg, MD, PhD

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0,1 or 2

Must not have

Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20

Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dose-escalation: up to 1 year; expansion and dose-opt part (mcl): 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new antibody drug (epcoritamab) to see if it is safe for humans. The trial has two parts, a dose-escalation part to test safety in humans for the first time, and an expansion part to test the drug's effectiveness.

Who is the study for?

This trial is for adults with various types of B-cell lymphoma that have relapsed or didn't respond to previous treatments, including an anti-CD20 monoclonal antibody. Participants should be in a stable condition (ECOG 0,1,2), have measurable disease and proper kidney and liver function. Those with CNS lymphoma involvement, other cancers, significant heart conditions, immune diseases requiring suppression therapy, recent CAR-T therapy or stem cell transplant are excluded.

What is being tested?

Epcoritamab (EPKINLY™/GEN3013) is being tested in this multi-phase trial to determine its safety and effectiveness against B-cell lymphomas. The study includes dose-escalation to find the right amount of drug needed (Phase 1), expansion to treat more patients at that dose (Phase 2a), and optimization to refine dosing further (Phase 2a).

What are the potential side effects?

Potential side effects of Epcoritamab may include reactions related to the infusion process itself such as fever or chills; it could also affect blood counts leading to increased risk of infections or bleeding. Organ inflammation might occur too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer is a type of B-cell neoplasm that is CD20 positive.

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My condition worsened after treatment with a specific antibody therapy, possibly combined with chemotherapy, or after a stem cell transplant.

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My condition is newly diagnosed or transformed diffuse large B-cell lymphoma.

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My condition is Marginal Zone Lymphoma (MZL).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with a specific experimental drug for my condition.

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I have not had CAR-T therapy in the last 30 days.

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I am eligible for a high-intensity treatment plan aimed at curing my cancer, followed by stem cell transplant.

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I have an autoimmune disease or need permanent immunosuppressive therapy.

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I am on medication for seizures.

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I have a known heart condition.

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My lymphoma affects my brain or spinal cord.

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I have or had cancer types other than the one I'm seeking treatment for.

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I cannot take any medication that lowers uric acid.

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I have had a stem cell transplant from my own cells within the last 100 days or any transplant from a donor.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dose-escalation: up to 1 year; expansion and dose-opt part (mcl): 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dose-escalation: up to 1 year; expansion and dose-opt part (mcl): 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and dose-escalation: up to 1 year; expansion and dose-opt part (mcl): 1.5 years for reporting.