Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05283720

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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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 | DecenTrialz