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GEN3013 (DuoBody®-CD3xCD20) Safety Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03625037
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : July 22, 2019
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma High-grade B-cell Lymphoma Primary Mediastinal Large B-cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Biological: GEN3013 (DuoBody®-CD3xCD20) Phase 1 Phase 2

Detailed Description:
The trial is an open-label, multi-center safety trial of GEN3013 (DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part (phase 1, first-in-human (FIH) and an expansion part phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Sequential Assignment
Intervention Model Description: A Minimum Anticipated Biologic Effect Level (MABEL) -derived starting (priming) dose of 4.0 μg (microgram) is administered as a flat dose. The priming dose for the first patient will be followed with a subsequent dose that will be as a maximum 12.8 μg (microgram) flat dose. Dose escalation steps are based on all available data with increments not exceeding a half-log10 (3.2-fold) increase in the accelerated titration part and not exceeding 100% (2-fold) increase in the standard titration part.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : December 30, 2025

Arm Intervention/treatment
Experimental: GEN3013 (DuoBody®-CD3xCD20)
Open label, single arm trial where GEN3013 will be administered
Biological: GEN3013 (DuoBody®-CD3xCD20)
GEN3013 will be administered in cycles of 4 weeks i.e. 28 days. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.

Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: DLTs are assessed during the first cycle (28 days) in each cohort ]
    To determine recommended phase 2 dose of GEN3013

  2. Adverse Events (AEs) [ Time Frame: AEs are collected throughout the study and up to 5 years after last patient first visit ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Secondary Outcome Measures :
  1. Cytokine measures [ Time Frame: During the first two cycles of treatment (1 cycle is 28 days), at unscheduled visits and up to 5 years after last patient first visit ]
    To establish tolerability of GEN3013 using an array-based ligand binding assay

  2. Area-under-the-concentration-time curve (AUC0-C last) [ Time Frame: Through study completion and up to 5 years after last patient first visit ]
    To establish the PK profile of GEN3013 after single and multiple doses

  3. Maximum Plasma Concentration (Cmax) of GEN3013 [ Time Frame: Through study completion and up to 5 years after last patient first visit ]
    To establish the PK profile of GEN3013 after single and multiple doses

  4. Presence of neutralizing anti-drug antibodies (ADAs) in blood (positive/negative). [ Time Frame: Through study completion and up to 5 years after last patient first visit ]
    To evaluate immunogenicity of GEN3013

  5. Reduction in tumor size [ Time Frame: Through study completion and up to 5 years after last patient first visit ]
    To evaluate the anti-lymphoma activity of GEN3013 as evaluated by Lugano classification (Cheson et al., 2014)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must be 18 years of age or older
  • Documented CD20+ mature B-cell neoplasm

    1. Diffuse large B-cell lymphoma - de novo or transformed
    2. High-grade B-cell lymphoma (Swerdlow et al., 2016)
    3. Primary mediastinal large B-cell lymphoma
    4. Follicular lymphoma
    5. Mantle cell lymphoma
    6. Small lymphocytic lymphoma
    7. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03625037

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Contact: Genmab A/S Trial Information +45 70202728

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Rigshospitalet Recruiting
Copenhagen, Denmark
Vejle Hospital Recruiting
Vejle, Denmark
VU University Medical Center Recruiting
Amsterdam, Netherlands
Erasmus MC University Medical Center Rotterdam Recruiting
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands
Institut Català d'Oncologia Not yet recruiting
Barcelona, Spain
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Plymouth University School of Medicine - Derriford Hospital Recruiting
Plymouth, United Kingdom
University Hospital Southampton NHS Foundation Trust Not yet recruiting
Southampton, United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Pieternella Lugtenburg, MD, PhD Erasmus MC University Medical Center Rotterdam
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Responsible Party: Genmab Identifier: NCT03625037    
Other Study ID Numbers: GCT3013-01
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid