Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

The trial is a global, multi-center safety trial of Epcoritamab, an antibody also known as GEN3013 (DuoBody®-CD3xCD20). The trial consists of three parts: a dose-escalation part (Phase 1, first-in-human (FIH)), an expansion part (Phase 2a) and a dose optimization part (Phase 2a)

View Full Description

Full Description

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in patients with relapsed, progressive or refractory B-Cell Lymphoma.

In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose optimization part will evaluate alternative priming and intermediate dose regimens of epcoritamab. All patients will receive Epcoritamab at the already established full dose.

View Eligibility Criteria

Eligibility Criteria

Main Inclusion Criteria Escalation Part (recruitment completed)

Documented CD20+ mature B-cell neoplasm

Diffuse large B-cell lymphoma - de novo or transformed
High-grade B-cell lymphoma
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.
ECOG performance status 0,1 or 2
Patients must have measurable disease by CT, MRI or PET-CT scan
Acceptable renal function
Acceptable liver function

Main Inclusion Criteria Expansion and Optimization Parts

Documented CD20 positive mature B cell neoplasm or CD20+ MCL
Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple hit)
Primary mediastinal large B cell lymphoma
Follicular lymphoma grade 3B
Histologic confirmed follicular lymphoma
Marginal zone lymphomas
Small lymphocytic lymphoma
Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)
At least 2 therapies including an anti CD20 monoclonal antibody containing chemotherapy combination regimen
Either failed prior autologous hematopoietic stem cell transplantation or ineligible for autologous stem cell transplantation due to age or comorbidities
At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes

NOTE: Other protocol defined Inclusion criteria may apply.

Main Exclusion Criteria Escalation, Expansion and Optimization Parts

Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
Known past or current malignancy other than inclusion diagnosis
AST, and/or ALT >3 × upper limit of normal
Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
Estimated CrCl <45 mLmin
Known clinically significant cardiovascular disease
Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
Seizure disorder requiring therapy (such as steroids or anti-epileptics)
Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration
Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue
Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation
Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in
Known human immunodeficiency virus (HIV) infection
Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
Pregnancy or breast feeding
Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient
Contraindication to all uric acid lowering agents

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

700

Study ID:

NCT03625037

Recruitment Status:

Recruiting

Sponsor:

Genmab

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 24 Locations for this study

See Locations Near You

Arizona Mayo Clinic
Phoenix Arizona, 85054, United States
University of California at San Francisco
San Francisco California, 94117, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Northside Hospital- The Blood Marrow Transplant Group
Atlanta Georgia, 30309, United States
University of Iowa Hospital and Clinics
Iowa City Iowa, 52242, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48334, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Hackensack Meridian Health
Hackensack New Jersey, 07601, United States
Levine Cancer institute/ Atrium Health
Charlotte North Carolina, 28204, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
OHSU Knight Cancer Institute
Portland Oregon, 97210, United States
Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health- Upstate
Greenville South Carolina, 29605, United States
UT Southwestern
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States
Monash Health
Clayton , , Australia
Concord Hospital
Concord , , Australia
St. Vincent Hospital
Fitzroy , , Australia
Integrated Clinical Oncology Network Pty Ltd (ICON)
Herston , , Australia
Royal Hobart Hospital RHH
Hobart , , Australia
St. George Hospital
Kogarah , , Australia
Cabrini Hospital
Malvern , , Australia
Sir Charles Gairdner Hospital
Nedlands , , Australia
Gold Coast Hospital
Southport , , Australia
St George Hospital
Sydney , , Australia
Tom Baker Cancer Care
Calgary , , Canada
Toronto-Sunnybrook Regional Cancer Ctr
Toronto , , Canada
Rigshospitalet
Copenhagen , , Denmark
Odense University Hospital
Odense , 5000 , Denmark
Vejle Hospital
Vejle , , Denmark
Helsinki University Hospital
Helsinki , , Finland
Kuopio University Hospital
Kuopio , , Finland
Tampere University Hospital
Tampere , , Finland
Hopital Henri Mondor
Créteil , , France
Hopital Huriez-CHRU Lille
Lille , , France
CHU Montpellier
Montpellier , , France
Hospital Saint-Louis
Paris , , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite , , France
Centre Henri Becquerel
Rouen cedex , , France
CHU de Tours-Hopital Bretonneau
Tours , , France
Institut Gustave Roussy
Villejuif , , France
Charite - Universitaetsmedizin Berlin
Berlin , , Germany
Klinik fur Innere Medizin Hamatologie and Onkologie
Berlin , , Germany
Universitaetsklinikum Koeln
Cologne , , Germany
Universitaetsklinikum Essen
Essen , , Germany
Johannes Gutenberg University
Mainz , , Germany
Der Universität Munchen Medizinische Klinik III LMU
München , , Germany
Ao Ss Antonio E Biagio Alessandria
Alessandria , , Italy
Policlinico S. Orsola-Ematologia LA Seragnoli
Bologna , , Italy
Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
Candiolo , , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , , Italy
IRCCS Ospedale San Raffaele
Milan , , Italy
Dong-A University Hospital
Busan , , Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , , Korea, Republic of
National Cancer Center
Goyang-si , , Korea, Republic of
Chonbuk National University Hospital
Jeonju , , Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University
Seoul , , Korea, Republic of
VU University Medical Center
Amsterdam , , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands More Info
Principal Investigator
Contact
Erasmus MC Cancer Institute
Rotterdam , , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , , Netherlands
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz , , Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk , , Poland
Pratia-McM
Kraków , , Poland
Uniwersytet Medyczny w Lublinie
Lublin , , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk , , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute
Warszawa , , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wrocław , , Poland
National University Hospital
Singapore , , Singapore
Singapore General Hospital
Singapore , , Singapore
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Germans Trias i Pujol
Badalona , , Spain
Hospital Universitario Vall dHebron
Barcelona , , Spain
Institut Catala de Oncologia
Barcelona , , Spain
Hospital Universitario Fundacin Jimnez Daz
Madrid , , Spain
Skåne University Hospital
Lund , , Sweden
Karolinska University Hospital Huddinge
Stockholm , , Sweden
Akademiska sjukhuset Uppsala University Hospital
Uppsala , , Sweden
University Hospital of Wales
Cardiff , , United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom
Plymouth University School of Medicine- Derriford Hospital
Plymouth , , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton , , United Kingdom
Royal Marsden NHS Foundation Trust
Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

700

Study ID:

NCT03625037

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.