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Diffuse Large B Cell LymphomaPhase 1/2EPCORE™ NHL-3NCT04542824

Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)

A Phase 1/2 study testing Epcoritamab (monotherapy), Epcoritamab and Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Genmab at 15 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants with relapsed, progressive or refractory B-cell lymphomas and Japanese participants with B-cell lymphomas that have achieved partial response (PR) or complete response (CR) following prior… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Epcoritamab (monotherapy), Epcoritamab and Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
15 sitesJapan
Study dates
20 Aug 2020to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Arm 2:
  • FL Grade 3b
  • Histologic evidence of transformation to an aggressive lymphoma
  • Contraindication to rituximab or lenalidomide
  • Unwilling or unable to take aspirin prophylaxis or prophylactic anticoagulant as clinically indicated
  • Arm 3:
Show all 12Show fewer
  • Contraindication to any of the individual drugs of the R-CHOP regimen
  • Arm 4:
  • Contraindication to any of the individual drugs of the GemOx regimen
  • Arm 5:
  • FL Grade 3b
  • Histologic evidence of transformation to an aggressive lymphoma

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Aichi Cancer Center Hospital

    Aichi

  • NHO Nagoya Medical Center

    Aichi

  • National Cancer Center Hospital East

    Chiba

  • Matsuyama Red Cross Hospital

    Ehime

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka

  • Fukushima Medical University Hospital

    Fukushima

  • Kagoshima University Hospital

    Kagoshima

  • Kyoto University Hospital

    Kyoto

  • Kindai University Hospital

    Osaka

  • Osaka University Hospital

    Osaka

  • Tohoku University Hoaspital

    Sendai, Miyagi, 980-8577

  • Cancer Institute Hospital of JFCR

    Tokyo

  • National Cancer Center Hospital

    Tokyo

  • Tokyo Medical University Hospital

    Tokyo

  • Yamagata University Hospital

    Yamagata

Other trials in Japan

About this study

Official title: Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts

The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants with relapsed, progressive or refractory B-cell lymphomas and Japanese participants with B-cell lymphomas that have achieved partial response (PR) or complete response (CR) following prior standard of care (SOC). The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2).

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 Japanese participants with relapsed, progressive or refractory B-cell lymphoma and Japanese participants with B-cell lymphomas that have achieved PR or CR.

Read more

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.

Part 2 of the trial will be initiated once the RP2D has been determined in Part 1. In Part 2, epcoritamab is investigated as a monotherapy and in combination with other SOC agents.

Read the detailed description

All participants in the trial will receive epcoritamab, as monotherapy or in combination with SOC. The following regimens will be investigated in Part 2:

Arm 1: epcoritamab monotherapy in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)

Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with R/R FL

Arm 3: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated DLBCL with high risk features

Arm 4: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL who either failed prior autologous hematopoietic stem cell transplantation (ASCT), or are ineligible for autologous HSCT.

Arm 5: epcoritamab maintenance in participants with FL who achieve a CR or a PR following first line (1L)/second line (2L) SOC treatment

Being tested
Epcoritamab (monotherapy), Epcoritamab, Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, Gemcitabine and oxaliplatin, Epcoritamab (maintenance)
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epcoritamab (monotherapy)Biological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    Epcoritamab will be administered subcutaneously in cycles of 4 weeks (i.e. 28 days)

  • EpcoritamabBiological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    Epcoritamab will be administered in combination with the respective SOC chemotherapy followed by epcoritamab monotherapy.

  • Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneDrug

    Also called R-CHOP

    21-day cycles

  • Gemcitabine and oxaliplatinDrug

    Also called GemOx

    28-day cycles

  • Epcoritamab (maintenance)Biological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    28-day cycle for Cycle 1 and then 56-day cycle from Cycle 2 through 13

  • Rituximab and lenalidomideDrug

    Also called R2

    28-day cycles.

Study groups in NCT04542824
Study groupRoleWhat they receive
Arm 1: EpcoritamabExperimentalIn participants with DLBCL/FL.
Receives: Biological: Epcoritamab (monotherapy)
Arm 2: Epcoritamab + Rituximab + LenalidomideExperimentalIn participants with R/R FL
Receives: Biological: Epcoritamab; Drug: Rituximab and lenalidomide
Arm 3: Epcoritamab + Rituximab + Cyclophosphamide+ Doxorubicin+ Vincristine + PrednisoneExperimentalIn participants with previously untreated DLBCL
Receives: Biological: Epcoritamab; Drug: Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
Arm 4: Epcoritamab + Gemcitabine + OxaliplatinExperimentalIn participants with relapsed/refractory DLBCL
Receives: Biological: Epcoritamab; Drug: Gemcitabine and oxaliplatin
Arm 5: Epcoritamab MaintenanceExperimentalIn participants with FL in CR or in PR following 1L or 2L SOC treatment
Receives: Biological: Epcoritamab (maintenance)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years

  2. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    Measured: DLTs are assessed during the first cycle (28 days) in each cohort

  3. Part 2, Arm 1: Objective Response Rate (ORR)

    Measured: Up to 1.5 years

  4. Part 2, Arms 2-4: Number of Participants with DLTs

    Measured: DLTs are assessed during the first cycle (28 days) in arms 2-4

  5. Part 2, Arms 2-5: Number of Participants with TEAEs

    Measured: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years

Secondary outcomes (18)

  1. Both parts: Area-under-the-concentration-time curve from Time 0 to Time of last dose (AUClast)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  2. Both parts: AUC from Time 0 to Infinity (AUCinf)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  3. Both parts: Maximum (Peak) Plasma Concentration (Cmax)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  4. Both parts: Time to Reach Cmax (Tmax)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  5. Both parts: Pre-dose (Trough) Concentrations (Cthrough)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  6. Both parts: Total Body Clearance of Drug from the Plasma (CL)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  7. Both parts: Volume of Distribution (Vd)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  8. Both parts: Elimination Half-life (t 1/2)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  9. Both parts: Number of Participants with Anti-Drug-Antibodies (ADAs)

    Measured: From first dose until treatment discontinuation, expected average of 1 year

  10. Part 2, Arm 1: Number of Participants with TEAEs

    Measured: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years

  11. Part 1 and Part 2, Arms 2-5: ORR

    Measured: Up to 1.5 years

  12. Both parts: CR Rate

    Measured: Up to 1.5 years

  13. Both parts: Duration of Response (DOR)

    Measured: Up to 1.5 years

  14. Both parts: Progression Free Survival (PFS)

    Measured: Up to 1.5 years

  15. Part 2: Duration of CR (DoCR)

    Measured: Up to 1.5 years

  16. Part 2: Time to Response (TTR)

    Measured: Up to 1.5 years

  17. Part 1 and Part 2 arm 1: Time to Next Anti-lymphoma Therapy (TTNT)

    Measured: Up to 1.5 years

  18. Both parts: Overall Survival (OS)

    Measured: Up to 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start20 Aug 2020
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1: Sequential Assignment Part 2: Parallel Group Assignment
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542824
Sponsor's protocol ID
GCT3013-04
Other IDs
JapicCTI-205408, jRCT2080225312
Acronym
EPCORE™ NHL-3
Status last verified
Oct 2026
First submitted
25 Aug 2020
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sinnollareddy M, Sanghavi K, Gibiansky L, Li T, Putnins M, Mohamed MF, Patah P, Favaro E, Gupta M, Parikh A, Xu S. Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma. Clin Pharmacokinet. 2026 Aug 1. doi: 10.1007/s40262-026-01661-1. Online ahead of print.

    PubMed 42541678

  • Li T, Tredennick A, Polhamus D, Putnins M, Liu S, Sanghavi K, Thalhauser CJ, Parikh A, Noorani B, Mohamed MF, Le Gallo C, Elliott B, Gupta M, Xu S. Epcoritamab Step-Up Dosing Regimen Selection and Optimization Using Repeated Time-to-Event Modeling for Cytokine Release Syndrome Risk Mitigation. Clin Pharmacol Ther. 2026 Aug;120(2):542-551. doi: 10.1002/cpt.70362. Epub 2026 Jul 7.

    PubMed 42411504

  • Izutsu K, Akahane D, Toubai T, Saito T, Mishima Y, Fujisaki T, Nishikori M, Kumode T, Suehiro Y, Ishitsuka K, Conlon R, Takahashi A, D'Angelo Mansson B, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese patients with relapsed or refractory follicular lymphoma: primary results of the EPCORE NHL-3 trial. Leuk Lymphoma. 2025 Oct;66(10):1913-1921. doi: 10.1080/10428194.2025.2525983. Epub 2025 Jul 9.

    PubMed 40632620

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Epcoritamab (monotherapy), Epcoritamab and Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Genmab at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542824, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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