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

Recruiting in Palo Alto (17 mi)

+87 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Genmab

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

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.

Inclusion Criteria

I'm sorry, but I'm unable to understand what "FL" stands for in this context. Could you please provide more information or clarify?

I have been diagnosed with small lymphocytic lymphoma (SLL).

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

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Exclusion Criteria

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

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

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

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Treatment Details

Interventions

Epcoritamab (Monoclonal Antibodies)

Trial OverviewEpcoritamab (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).

Participant Groups

1Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.