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History of Changes for Study: NCT03625037
GEN3013 (DuoBody®-CD3xCD20) Safety Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Latest version (submitted May 6, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 9, 2018 None (earliest Version on record)
2 August 14, 2018 Study Status
3 September 13, 2018 Study Status and Contacts/Locations
4 September 27, 2018 Contacts/Locations and Study Status
5 January 7, 2019 Contacts/Locations, Study Status and Eligibility
6 January 14, 2019 Contacts/Locations and Study Status
7 February 26, 2019 Contacts/Locations and Study Status
8 April 12, 2019 Study Status and Contacts/Locations
9 July 19, 2019 Study Status and Contacts/Locations
10 August 20, 2020 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility and Sponsor/Collaborators
11 January 8, 2021 Contacts/Locations, Study Status and Study Design
12 February 11, 2021 Contacts/Locations, Study Status, Study Identification, Eligibility and Study Design
13 July 27, 2021 Study Status and Contacts/Locations
14 June 17, 2022 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status, Study Description, Eligibility and Study Identification
15 October 18, 2022 Outcome Measures, Study Description, Study Status, Study Identification, Contacts/Locations, Eligibility and Study Design
16 February 7, 2023 Study Status
17 February 23, 2023 Study Status
18 March 27, 2023 Outcome Measures, Study Status, Study Identification, Study Description, Eligibility and Conditions
19 May 25, 2023 Study Status, References, Arms and Interventions and Study Description
20 May 30, 2023 Study Status and Study Identification
21 June 27, 2023 Study Status, Contacts/Locations and Study Design
22 August 7, 2023 Contacts/Locations, Study Status and Study Identification
23 January 2, 2024 Study Status
24 February 14, 2024 Outcome Measures, Contacts/Locations, Study Description, Study Status, Eligibility, Arms and Interventions, Study Design and Conditions
25 March 4, 2024 Study Status and Study Identification
26 March 25, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
27 April 4, 2024 Study Status
28 May 6, 2024 Study Status and Study Identification
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Study NCT03625037
Submitted Date:  January 14, 2019 (v6)
Open or close this module Study Identification
Unique Protocol ID: GCT3013-01
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: June 26, 2018
Primary Completion: January 30, 2022 [Anticipated]
Study Completion: December 30, 2025 [Anticipated]
First Submitted: June 7, 2018
First Submitted that
Met QC Criteria:		 August 9, 2018
First Posted: August 10, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 14, 2019
Last Update Posted: January 15, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Genmab
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
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
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
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.
Number of Arms: 1
Masking: None (Open Label)
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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)
Open or close this module Contacts/Locations
Central Contact Person: Emilia Kristiina Jørgensen, MSc
Telephone: +45 3377 9686
Email: ekj@genmab.com
Study Officials: Pieternella Lugtenburg, MD, PhD
Principal Investigator
Erasmus MC University Medical Center Rotterdam
Locations: Denmark
Rigshospitalet
[Not yet recruiting]
Copenhagen, Denmark
Vejle Hospital
[Not yet recruiting]
Vejle, Denmark
Netherlands
VU University Medical Center
[Recruiting]
Amsterdam, Netherlands
Erasmus MC University Medical Center Rotterdam
[Recruiting]
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
[Recruiting]
Utrecht, Netherlands
Spain
Institut Català d'Oncologia
[Not yet recruiting]
Barcelona, Spain
United Kingdom
The Christie NHS Foundation Trust
[Not yet 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
[Not yet recruiting]
Sutton, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services