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Diffuse Large B-Cell LymphomaPhase 3NCT07226752

A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China

A Phase 3 study testing Epcoritamab and Investigator's Choice Chemotherapy in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 23 sites in China.

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 purpose of this Chinese sub-study trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Epcoritamab and Investigator's Choice Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
23 sitesChina
Study dates
8 Oct 2022to 14 Jun 2028
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis.
  2. One of the confirmed histologies below with CD20-positivity:
  3. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL) 2. "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL 3. FL Grade 3B 4. T-cell/histiocyte-rich large B-cell lymphoma
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2 4. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening 5. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI) 6. Acceptable renal and liver function 7. Life expectancy >2 months on standard of care treatment

Main Exclusion Criteria:

  1. Primary Central Nervous System (CNS) tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Major surgery within 4 weeks prior to randomization
  4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  6. Autologous stem cell transplant (ASCT) within 100 days of randomization
  7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Beijing Cancer Hospital

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Peking University Third Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • West China Hospital, Sichuan University

    Chengdu

  • The Second Hospital of Dalian Medical University

    Dalian

  • Guangdong Provincial Peoples Hospital

    Guandong

  • Guangxi Medical University Affiliated Tumor Hospital

    Guangxi

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Hubei Cancer Hospital

    Hubei

  • Hunan Cancer Hospital

    Hunan

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Qingdao Central Hospital

    Qingdao

  • Shanxi Provincial Cancer Hospital

    Shanxi

  • Shengjing Hospital of China Medical University

    Shenyang

  • Shenzhen Peoples Hospital

    Shenzhen

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Yantai Yuhuangding Hospital

    Yantai

  • Henan Cancer Hospital

    Zhengzhou

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Zhenjiang

Other trials in China

About this study

Official title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

The purpose of this Chinese sub-study trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin [R-GemOx], or bendamustine + rituximab [BR]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT).

Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously.

Read more

Trial details include:

The trial duration will be up to 5 years after last participant is randomized. All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death.

The estimated trial duration for an individual participant depends upon the treatment arm assigned:

Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events.

Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either:

R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.

Read the detailed description

This Chinese sub-study is an open label, multi-center, phase-3 randomized trial of epcoritamab. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in participants with relapsed, refractory DLBCL who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

This study is a sub-study of the master protocol GCT3013-05 (NCT04628494).

Being tested
Epcoritamab, Investigator's Choice Chemotherapy
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • EpcoritamabBiological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.

  • Investigator's Choice ChemotherapyDrug

    Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.

Study groups in NCT07226752
Study groupRoleWhat they receive
Epcoritamab (GEN3013; DuoBody®CD3xCD20)ExperimentalEpcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met.
Receives: Biological: Epcoritamab
Investigator's choice of chemotherapyActive comparatorR-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Receives: Drug: Investigator's Choice Chemotherapy

What is being measured

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

  1. Overall Survival (OS)

    Measured: Up to approximately 5 years

Secondary outcomes (10)

  1. Progression Free Survival (PFS)

    Measured: Up to approximately 5 years

  2. Overall Response Rate (ORR)

    Measured: Up to approximately 5 years

  3. Complete Response (CR) Rate

    Measured: Up to approximately 5 years

  4. Duration of Response (DOR)

    Measured: Up to approximately 5 years

  5. Time to Response (TTR)

    Measured: Up to approximately 5 years

  6. Time to Next Anti-lymphoma Therapy (TTNT)

    Measured: Up to approximately 5 years

  7. Number of Participants with Adverse Events (AEs)

    Measured: Up to approximately 5 years

  8. Number of Participants with Dose Interruptions and Delays

    Measured: Up to approximately 5 years

  9. Number of Participants with an Anti-epcoritamab Antibody Response

    Measured: Up to approximately 5 years

  10. Changes from Baseline in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    Measured: Baseline up to approximately 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 posted10 Nov 2025
  2. Study start8 Oct 2022
  3. Primary completion13 Oct 2025
  4. Study completion14 Jun 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07226752
Sponsor's protocol ID
GCT3013-05 Sub-study
Other IDs
CTR20221558
Status last verified
May 2026
First submitted
6 Nov 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab and Investigator's Choice Chemotherapy in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 23 sites in China.

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

Who may be eligible to take part?

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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall Survival (OS) (time frame: Up to approximately 5 years). 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 NCT07226752.

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 5 May 2026.

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