Actively Recruiting
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
Led by Genmab · Updated on 2026-05-06
496
Participants Needed
76
Research Sites
541 weeks
Total Duration
On this page
Sponsors
G
Genmab
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
CONDITIONS
Official Title
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20+ disease, including DLBCL NOS or high-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations
- Diagnosis of follicular lymphoma (FL) Grade 3B, or FL Grade 1 to 3a without transformation to aggressive lymphoma
- Diagnosis of mantle cell lymphoma (MCL) with CD20+ disease and evidence of cyclin D1 overexpression or t(11;14) translocation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, except Arm 6A where it must be 0 to 1
- At least one measurable disease site confirmed by PET/CT scan and at least one measurable nodal lesion (>1.5 cm) or extra-nodal lesion (>1.0 cm) on CT or MRI
You will not qualify if you...
- Prior treatment with epcoritamab or any bispecific antibody targeting CD3 and CD20
- Unresolved toxicities from prior anticancer therapy above Grade 2 (except alopecia) according to CTCAE v5.0
- Failure to meet other eligibility criteria such as laboratory or cardiac requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, United States, 85719
Completed
2
Yale University School of Medicine /ID# 242089
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Christiana Care Health Service /ID# 242301
Newark, Delaware, United States, 19713
Actively Recruiting
4
Tampa General Hospital /ID# 246748
Tampa, Florida, United States, 33606
Actively Recruiting
5
Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, United States, 30322
Completed
6
University of Maryland, Baltimore /ID# 242218
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City, Missouri, United States, 64114-4859
Completed
8
Northwell Health - Monter Cancer Center /ID# 245435
Lake Success, New York, United States, 11042
Actively Recruiting
9
Icahn School of Medicine at Mount Sinai /ID# 242123
New York, New York, United States, 10029
Actively Recruiting
10
Novant Health Presbyterian Medical Center /ID# 242148
Charlotte, North Carolina, United States, 28204
Completed
11
East Carolina University - Brody School of Medicine /ID# 242506
Greenville, North Carolina, United States, 27834
Actively Recruiting
12
Novant Health Forsyth Medical Center /ID# 242198
Winston-Salem, North Carolina, United States, 27103
Completed
13
Thomas Jefferson University Hospital /ID# 242077
Philadelphia, Pennsylvania, United States, 19107
Completed
14
Fox Chase Cancer Center /ID# 242106
Philadelphia, Pennsylvania, United States, 19111
Completed
15
Thompson Cancer Survival Ctr /ID# 242150
Knoxville, Tennessee, United States, 37916
Completed
16
Joe Arrington Cancer Research /ID# 242226
Lubbock, Texas, United States, 79410
Completed
17
Swedish Medical Center - Seattle /ID# 242269
Seattle, Washington, United States, 98104
Actively Recruiting
18
MultiCare Institute for Research & Innovation /ID# 242127
Tacoma, Washington, United States, 98405
Completed
19
Beijing Cancer Hospital /ID# 252303
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
20
Fudan University Cancer Hospital /ID# 252292
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
21
Fakultni Nemocnice Brno - Jihlavska /ID# 242683
Brno, Brno-mesto, Czechia, 625 00
Actively Recruiting
22
Fakultní nemocnice Hradec Králové - Sokolská /ID# 241722
Hradec Králové, Hradec Kralove, Czechia, 500 05
Actively Recruiting
23
Fakultni Nemocnice Ostrava /ID# 242684
Ostrava, Ostrava-mesto, Czechia, 708 52
Actively Recruiting
24
Vseobecna Fakultni nemocnice v Praze /ID# 242685
Prague, Praha 17, Czechia, 128 00
Actively Recruiting
25
Aarhus Universitetshospital - Skejby /ID# 242670
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
26
Aalborg University Hospital /ID# 242734
Aalborg, North Denmark, Denmark, 9000
Completed
27
CHU Clermont-Ferrand /ID# 242344
Clermont, Auvergne-Rhône-Alpes, France, 63100
Actively Recruiting
28
CHU de Rennes - PONTCHAILLOU /ID# 242339
Rennes, Brittany Region, France, 35000
Actively Recruiting
29
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 242342
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
Actively Recruiting
30
CHRU Lille - Hopital Claude Huriez /ID# 242335
Lille, Nord, France, 59037
Completed
31
IUCT Oncopole /ID# 242340
Toulouse, Occitanie, France, 31059
Completed
32
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337
Créteil, Paris, France, 94010
Actively Recruiting
33
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
34
HCL - Hopital Lyon Sud /ID# 242349
Pierre-Bénite, Rhone, France, 69495
Actively Recruiting
35
Hopital Saint-Louis /ID# 242336
Paris, France, 75010
Actively Recruiting
36
Hopital Pitie Salpetriere /ID# 242343
Paris, Île-de-France Region, France, 75013
Actively Recruiting
37
Universitaetsklinikum Ulm /ID# 244265
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
38
Klinikum Augsburg /ID# 244523
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
39
Universitaetsklinikum Regensburg /ID# 244517
Regensburg, Bavaria, Germany, 93042
Actively Recruiting
40
Universitaetsklinikum Wuerzburg /ID# 245453
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
41
Universitaetsklinikum Giessen und Marburg /ID# 245308
Marburg, Hesse, Germany, 35043
Completed
42
Universitaetsklinikum Leipzig /ID# 245513
Leipzig, Saxony, Germany, 04103
Actively Recruiting
43
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
44
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
Kaposvár, Somogy County, Hungary, 7400
Actively Recruiting
45
Semmelweis Egyetem /ID# 242454
Budapest, Hungary, 1085
Actively Recruiting
46
Orszagos Onkologiai Intezet /ID# 242458
Budapest, Hungary, 1122
Actively Recruiting
47
Rabin Medical Center. /ID# 243014
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
48
Hadassah Medical Center-Hebrew University /ID# 243013
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
49
The Chaim Sheba Medical Center /ID# 243010
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
50
Tel Aviv Sourasky Medical Center /ID# 243012
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
51
Hokkaido University Hospital /ID# 248999
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
52
Kyoto University Hospital /ID# 248997
Kyoto, Kyoto, Japan, 606-8507
Completed
53
National Cancer Center Hospital /ID# 248995
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
54
Maastricht Universitair Medisch Centrum /ID# 243317
Maastricht, Limburg, Netherlands, 6229 HX
Completed
55
Vrije Universiteit Medisch Centrum /ID# 243319
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
56
Leids Universitair Medisch Centrum /ID# 243316
Leiden, South Holland, Netherlands, 2333 ZA
Completed
57
Duplicate_Erasmus Medisch Centrum /ID# 243315
Rotterdam, South Holland, Netherlands, 3015 GD
Completed
58
Universitair Medisch Centrum Groningen /ID# 243318
Groningen, Netherlands, 9713 GZ
Completed
59
Seoul National University Bundang Hospital /ID# 242404
Seongnam-si, Gyeonggido, South Korea, 13620
Actively Recruiting
60
Seoul National University Hospital /ID# 242402
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
61
Asan Medical Center /ID# 242400
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
62
Samsung Medical Center /ID# 242401
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
63
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
Seoul, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
64
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
Badalona, Barcelona, Spain, 08916
Actively Recruiting
65
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 243261
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
66
Clinica Universidad de Navarra - Pamplona /ID# 245031
Pamplona, Navarre, Spain, 31008
Actively Recruiting
67
Hospital Universitario Vall de Hebron /ID# 243260
Barcelona, Spain, 08035
Actively Recruiting
68
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
Madrid, Spain, 28027
Actively Recruiting
69
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
Madrid, Spain, 28040
Actively Recruiting
70
Hospital Universitario 12 de Octubre /ID# 243262
Madrid, Spain, 28041
Actively Recruiting
71
Hospital Universitario de Salamanca /ID# 243368
Salamanca, Spain, 37711
Actively Recruiting
72
Hospital Universitario Virgen del Rocio /ID# 243267
Seville, Spain, 41013
Actively Recruiting
73
Hospital Clinico Universitario de Valencia /ID# 243269
Valencia, Spain, 46010
Actively Recruiting
74
China Medical University Hospital /ID# 242893
Taichung, Taiwan, 40447
Actively Recruiting
75
National Cheng Kung University Hospital /ID# 242894
Tainan, Taiwan, 704
Actively Recruiting
76
Taipei Veterans General Hosp /ID# 242892
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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