GEN3013, Epcoritamab Trial In Patients With Relapsed, Progressive Or Refractory B-Cell Lymphoma EPCORE™ NHL-1

Overview

About this study

The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Documented CD20+ mature B-cell neoplasm:
    • Diffuse large B-cell lymphoma - de novo or transformed;
    • High-grade B-cell lymphoma (Swerdlow et al., 2016);
    • Primary mediastinal large B-cell lymphoma;
    • Follicular lymphoma;
    • Mantle cell lymphoma;
    • Small lymphocytic lymphoma;
    • Marginal zone lymphoma (nodal, extranodal or mucosa associated).
  • Relapsed, progressive and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • Documentation of CD20+ mature B-cell neoplasm based on any representative pathology report.
  • Patients must have measurable disease by Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography(PET)/CT scan.
  • Acceptable renal function.
  • Acceptable liver function.

Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma.
  • Known clinically significant cardiac disease:
    • Chronic ongoing infectious diseases (except hepatitis B or hepatitis C) requiring treatment (excluding prophylactic treatment).
  • Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue.
  • Active hepatitis B or hepatitis C.
  • Known human immunodeficiency virus (HIV) infection.
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed Consent Form (ICF).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Allison Rosenthal, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20507296

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