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 · tracked via the Priya Life Science China tracker

Sponsor

Genmab

Phase

Phase 3

Started

2022-10-08

Last updated

2026-05-05

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

EpcoritamabInvestigator's Choice Chemotherapy

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

Investigator's Choice Chemotherapy: Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: 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: 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.

Primary outcome measure(s)

Overall Survival (OS) — Up to approximately 5 years

Trial sites (23)

Facility	City	Region
Affiliated Hospital of Hebei University	Baoding	China
Beijing Cancer Hospital	Beijing	China
Beijing Tongren Hospital, Capital Medical University	Beijing	China
Peking University Third Hospital	Beijing	China
The First Hospital of Jilin University	Changchun	China
West China Hospital, Sichuan University	Chengdu	China
The Second Hospital of Dalian Medical University	Dalian	China
Guangdong Provincial Peoples Hospital	Guandong	China
Guangxi Medical University Affiliated Tumor Hospital	Guangxi	China
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	China
Hubei Cancer Hospital	Hubei	China
Hunan Cancer Hospital	Hunan	China
The First Affiliated Hospital of Nanchang University	Nanchang	China
Qingdao Central Hospital	Qingdao	China
Shanxi Provincial Cancer Hospital	Shanxi	China
Shengjing Hospital of China Medical University	Shenyang	China
Shenzhen Peoples Hospital	Shenzhen	China
The First Affiliated Hospital of Soochow University	Suzhou	China
Tianjin Medical University Cancer Institute and Hospital	Tianjin	China
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	China
Yantai Yuhuangding Hospital	Yantai	China
Henan Cancer Hospital	Zhengzhou	China
The Second Affiliated Hospital Zhejiang University School of Medicine	Zhenjiang	China

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GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer Recruiting

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Active, not recruiting

A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Active, not recruiting

Other trials for the same condition

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) Active, not recruiting

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) Active, not recruiting

PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma Recruiting

A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) Recruiting

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226752 on ClinicalTrials.gov ↗ ← All trials in China