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

NCT07226752 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GCT3013-05 Sub-studyCTR20221558
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 23

Brief 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. 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. 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.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to approximately 5 years

Secondary Outcomes (10)

• Progression Free Survival (PFS)

  Up to approximately 5 years

• Overall Response Rate (ORR)

  Up to approximately 5 years

• Complete Response (CR) Rate

  Up to approximately 5 years

• Duration of Response (DOR)

  Up to approximately 5 years

• Time to Response (TTR)

  Up to approximately 5 years

Study Arms (2)

Epcoritamab (GEN3013; DuoBody®CD3xCD20)

EXPERIMENTAL

Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met.

Biological: Epcoritamab

Investigator's choice of chemotherapy

ACTIVE COMPARATOR

R-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

Drug: Investigator's Choice Chemotherapy

Interventions

Epcoritamab BIOLOGICAL

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

Also known as: GEN3013, DuoBody®-CD3xCD20, EPKINLY™

Epcoritamab (GEN3013; DuoBody®CD3xCD20)

Investigator's Choice Chemotherapy DRUG

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

Investigator's choice of chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• One of the confirmed histologies below with CD20-positivity:
• \. 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
• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Genmab: lead
• AbbVie: collaborator

Study Sites (23)

Affiliated Hospital of Hebei University

Baoding, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

The Second Hospital of Dalian Medical University

Dalian, China

Location

Guangdong Provincial Peoples Hospital

Guandong, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Guangxi, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Hubei Cancer Hospital

Hubei, China

Location

Hunan Cancer Hospital

Hunan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Qingdao Central Hospital

Qingdao, China

Location

Shanxi Provincial Cancer Hospital

Shanxi, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

Shenzhen Peoples Hospital

Shenzhen, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

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

Wuhan, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhenjiang, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: October 8, 2022
• Primary Completion: October 13, 2025
• Study Completion (Estimated): June 14, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)