First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
NCT ID: NCT03625037
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
666 participants
INTERVENTIONAL
2018-06-26
2029-01-31
Brief Summary
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* The dose schedule for epcoritamab
* The side effects seen with epcoritamab
* What the body does with epcoritamab once it is administered
* What epcoritamab does to the body once it is administered
* How well epcoritamab works against relapsed and/or refractory B-cell lymphoma
The trial consists of 3 parts:
* a dose-escalation part (Phase 1, first-in-human \[FIH\])
* an expansion part (Phase 2a)
* a dose-optimization part (OPT) (Phase 2a)
The trial time for each participant depends on which trial part the participant enters:
* For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
* For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.
All participants will receive active drug, and no participants will be given placebo.
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Detailed Description
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In the expansion part, additional participants 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-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:
* Diffuse large B-cell lymphoma (DLBCL)
* Follicular lymphoma (FL)
* Mantle cell lymphoma (MCL)
All participants will receive epcoritamab at the RP2D.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Epcoritamab
Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Epcoritamab
Administered as specified in the treatment arm.
Interventions
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Epcoritamab
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. DLBCL - de novo or transformed
2. HGBCL
3. PMBCL
4. FL
5. MCL
6. SLL
7. MZL (nodal, extranodal or mucosa associated)
* Relapsed 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.
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
* Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan
* Acceptable renal function.
* Acceptable liver function.
* Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
* DLBCL, de novo or transformed (including double hit or triple hit).
* PMBCL
* FL grade 3B
* Histologic confirmed FL
* MZL
* SLL
* MCL (prior Bruton's tyrosine kinase inhibitor \[BTKi\] 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 (HSCT) 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.
Exclusion Criteria
* Known past or current malignancy other than inclusion diagnosis.
* Aspartate aminotransferase (AST), and/or alanine transaminase (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 Creatinine clearance (CrCl) \<45 milliliters (mL)/min.
* Known clinically significant cardiovascular disease.
* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (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 (deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\]-positive) or hepatitis C (ribonucleic acid \[RNA\] PCR-positive infection). Participants with evidence of prior hepatitis B (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 Informed consent form (ICF).
* Pregnancy or breast feeding.
* Participant 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 participant.
* Contraindication to all uric acid lowering agents.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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Arizona Mayo Clinic
Phoenix, Arizona, United States
University of California at San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Monash Health
Clayton, , Australia
Concord Hospital
Concord, , Australia
St. Vincent Hospital
Fitzroy, , Australia
Royal Brisbane and Women's Hospital
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
Westmead Hospital
Sydney, , Australia
Tom Baker Cancer Care
Calgary, , Canada
Toronto-Sunnybrook Regional Cancer Ctr
Toronto, , Canada
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , 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
CHU Montpellier
Montpellier, , France
Hospital Saint-Louis
Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
CHU de Tours-Hopital Bretonneau
Tours, , 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
VU University Medical Center
Amsterdam, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
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
Gdansk, , Poland
Pratia-McM
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw, , Poland
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, 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
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
Countries
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References
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Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.
Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, Christensen JH, Hess B, Tilly H, Cordoba R, Lewis DJ, Okada C, Hutchings M, Clausen MR, Sancho JM, Cochrane T, Leppa S, Chamuleau MED, Gernhardt D, Altintas I, Liu Y, Ahmadi T, Dinh MH, Hoehn D, Favaro E, Elliott B, Thieblemont C, Vose JM. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Aug;11(8):e593-e605. doi: 10.1016/S2352-3026(24)00166-2. Epub 2024 Jun 15.
Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274.
Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25.
Phillips T, Lugtenburg P, Kalsekar A, Mutebi A, Wang A, Blaedel J, Kosa K, Martin S, Sacchi M, Kilavuz N, Thieblemont C. Improvements in Patient-Reported Outcomes in Relapsed or Refractory Large B-Cell Lymphoma Patients Treated With Epcoritamab. Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):e78-e87.e2. doi: 10.1016/j.clml.2023.11.005. Epub 2023 Nov 27.
Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
Other Identifiers
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2017-001748-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL64317.078.17
Identifier Type: REGISTRY
Identifier Source: secondary_id
241053
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504802-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
GCT3013-01
Identifier Type: -
Identifier Source: org_study_id
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