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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

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

EPCORE™ NHL-1 Trial 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.Check my eligibility

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).See study design

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.

EPCORE™ NHL-1 Trial Eligibility Criteria

Inclusion Criteria

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

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

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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).

EPCORE™ NHL-1 Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-Escalation: Dose Limiting Toxicity (DLT)

Dose-Escalation: Number of Participants with Adverse Events (AEs)

Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events

+1 more

Secondary outcome measures

All Parts: Area under Curve (AUC) of Epcoritamab

All Parts: Half Life of Epcoritamab (t1/2)

All Parts: Immunophenotyping for Absolute T-cell and B-cell

+32 more

EPCORE™ NHL-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

952 Previous Clinical Trials

499,084 Total Patients Enrolled

GenmabLead Sponsor

56 Previous Clinical Trials

11,566 Total Patients Enrolled

Study OfficialStudy DirectorGenmab

9 Previous Clinical Trials

1,963 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03625037 — Phase 1 & 2

B-Cell Lymphoma Research Study Groups: Epcoritamab

B-Cell Lymphoma Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT03625037 — Phase 1 & 2

Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03625037 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are allowed to join this clinical trial?

"To run this trial, we need to enroll 700 eligible patients from our pool of applicants. Patients can choose to participate at one of our many clinical sites, such as the Colorado Blood Cancer Institute in Denver or Rhode island Hospital in Providence."

Answered by AI

Has this clinical trial been done before?

"Epcoritamab has been the focus of medical research since 2018. After the completion of the first sponsored study by Genmab, Phase 1 & 2 drug approval was received in 2018. Currently, there are 6 different ongoing trials for Epcoritamab located in 56 cities and 26 countries worldwide.."

Answered by AI

Are researchers still looking for people to enroll in this trial?

"Yes, as can be seen on clinicaltrials.gov, this study is currently looking for participants. This trial was originally posted on July 3rd 2018 and received its latest update on October 18th 2022."

Answered by AI

Could you elaborate on other research projects that have used Epcoritamab?

"There are six ongoing clinical trials studying the effects of epcoritamab, one of which is in phase three. The majority of these studies originate from Solna, California; however, there are 509 research sites conducting these investigations."

Answered by AI

At how many different sites is this trial being conducted?

"The clinical trial is currently open to patients at Colorado Blood Cancer Institute in Denver, Rhode island, Rhode Island Hospital in Providence, Nebraska, University of Nebraska Medical Center in Omaha and 18 other locations."

Answered by AI

Recent research and studies

The LancetJournal

Dose Escalation of Subcutaneous Epcoritamab in Patients with Relapsed or Refractory B-cell Non-hodgkin Lymphoma: An Open-label, Phase 1/2 Study

Hutchings, Martin, Rogier Mous, Michael Roost Clausen, Peter Johnson, Kim M Linton, Martine E D Chamuleau, David John Lewis, et al.. 2021. “Dose Escalation of Subcutaneous Epcoritamab in Patients with Relapsed or Refractory B-cell Non-hodgkin Lymphoma: An Open-label, Phase 1/2 Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)00889-8.

The LancetJournal

Dose Escalation of Subcutaneous Epcoritamab in Patients with Relapsed or Refractory B-cell Non-hodgkin Lymphoma: An Open-label, Phase 1/2 Study

clinicaltrials.govStudy

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

2018. "First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03625037.

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