A Phase 3 interventional study of Epcoritamab and Investigator's Choice Chemotherapy in Diffuse Large B-Cell Lymphoma, sponsored by Genmab. Active, not recruiting at 23 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Genmab · Phase 3, Interventional, and Treatment
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.
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).
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's enrollment of 72 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Genmab is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 12 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
1. 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
3. 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:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met.
Biological: Epcoritamab
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
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Also known as: GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Overall Survival (OS)
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
Time frame: Up to approximately 5 years
Complete Response (CR) Rate
Time frame: Up to approximately 5 years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Time to Response (TTR)
Time frame: Up to approximately 5 years
Time to Next Anti-lymphoma Therapy (TTNT)
Time frame: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Number of Participants with Dose Interruptions and Delays
Time frame: Up to approximately 5 years
Number of Participants with an Anti-epcoritamab Antibody Response
Time frame: Up to approximately 5 years
Changes from Baseline in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Time frame: Baseline up to approximately 5 years
Plan to share: No
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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