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Status:

ACTIVE_NOT_RECRUITING

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Lead Sponsor:

Genmab

Collaborating Sponsors:

AbbVie

Conditions:

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Ly...

Detailed Description

A Phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epco...

Eligibility Criteria

Inclusion

  • Key Inclusion Criteria
  • Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7.
  • Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
  • Acceptable organ function at screening
  • CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
  • If of childbearing potential participant must practicing a highly effective method of birth control
  • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
  • Arm 1:
  • Newly diagnosed DLBCL
  • DLBCL, not otherwise specified (NOS)
  • "Double-hit" or "triple-hit" DLBCL
  • FL Grade 3B
  • Arm 2: R/R FL
  • Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
  • Arm 4:
  • Documented R/R DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "Double-hit" or "triple-hit" DLBCL
  • FL Grade 3B
  • Arm 5:
  • Documented R/R DLBCL and ineligible for HDT-ASCT
  • DLBCL, NOS
  • "Double-hit" or "triple-hit" DLBCL
  • FL Grade 3B
  • Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
  • Arm 7:
  • FL Grade 1-3A
  • If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
  • Arm 8:
  • Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline
  • T-cell/histiocyte rich DLBCL
  • "Double-hit" or "triple-hit" DLBCL
  • FL Grade 3B
  • Arm 9:
  • R/R FL
  • Progressed within 24 months of initiating first-line treatment
  • Arm 10:
  • Documented R/R DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "Double-hit" or "triple-hit" DLBCL
  • FL Grade 3B
  • Key Exclusion Criteria
  • Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
  • Any prior treatment with a bispecific antibody targeting CD3 and CD20.
  • Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
  • Clinically significant cardiovascular disease
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
  • Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  • Known history of seropositivity of human immunodeficiency virus (HIV)
  • Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
  • Neuropathy \> grade 1
  • Receiving immunostimulatory agent
  • Prior allogeneic HSCT
  • Current seizure disorder requiring anti-epileptic therapy
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion

    Key Trial Info

    Start Date :

    November 3 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 30 2027

    Estimated Enrollment :

    543 Patients enrolled

    Trial Details

    Trial ID

    NCT04663347

    Start Date

    November 3 2020

    End Date

    September 30 2027

    Last Update

    January 9 2026

    Active Locations (57)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 15 (57 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Cedars-Sinai Medical Center

    Los Angeles, California, United States, 90048

    3

    David Geffen School of Medicine at UCLA

    Los Angeles, California, United States, 90095

    4

    University of California San Francisco

    San Francisco, California, United States, 94143

    Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) | DecenTrialz