Clinical Trials /

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

NCT03625037

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Double-Hit Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Mediastinal Large B-Cell Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: GEN3013 (DuoBody®-CD3xCD20) Safety Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: GCT3013-01
  • NCT ID: NCT03625037

Conditions

  • 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

Interventions

DrugSynonymsArms
GEN3013 (DuoBody®-CD3xCD20)GEN3013 (DuoBody®-CD3xCD20)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
GEN3013 (DuoBody®-CD3xCD20)ExperimentalOpen label, single arm trial where GEN3013 will be administered

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patient must be 18 years of age or older
    
              -  Documented 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.
    
              -  CD20 positivity at most recent (previous or current) representative tumor biopsy based
                 on the 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)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Dose Limiting Toxicities (DLTs)
    Time Frame:DLTs are assessed during the first cycle (28 days) in each cohort
    Safety Issue:
    Description:To determine recommended phase 2 dose of GEN3013

    Secondary Outcome Measures

    Measure: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
    Safety Issue:
    Description:To establish tolerability of GEN3013 using an array-based ligand binding assay
    Measure:Area-under-the-concentration-time curve (AUC0-C last)
    Time Frame:Through study completion and up to 5 years after last patient first visit
    Safety Issue:
    Description:To establish the PK profile of GEN3013 after single and multiple doses
    Measure:Maximum Plasma Concentration (Cmax) of GEN3013
    Time Frame:Through study completion and up to 5 years after last patient first visit
    Safety Issue:
    Description:To establish the PK profile of GEN3013 after single and multiple doses
    Measure: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
    Safety Issue:
    Description:To evaluate immunogenicity of GEN3013
    Measure:Reduction in tumor size
    Time Frame:Through study completion and up to 5 years after last patient first visit
    Safety Issue:
    Description:To evaluate the anti-lymphoma activity of GEN3013 as evaluated by Lugano classification (Cheson et al., 2014)

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Genmab

    Last Updated