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New shot shows promise for tough lymphoma cases

NCT ID NCT07226752

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called epcoritamab (given as a shot under the skin) against standard chemotherapy for people with diffuse large B-cell lymphoma that has come back or stopped responding to treatment. About 72 participants in China will be randomly assigned to get either the new drug or one of two standard chemo regimens. The main goal is to see if epcoritamab helps people live longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

72 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B cell lymphoma

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, China

  • Beijing Cancer Hospital

    Beijing, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, China

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

    Wuhan, China

  • Guangdong Provincial Peoples Hospital

    Guandong, China

  • Guangxi Medical University Affiliated Tumor Hospital

    Guangxi, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hubei Cancer Hospital

    Hubei, China

  • Hunan Cancer Hospital

    Hunan, China

  • Peking University Third Hospital

    Beijing, 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 Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Zhenjiang, China

  • The Second Hospital of Dalian Medical University

    Dalian, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, China

  • West China Hospital, Sichuan University

    Chengdu, China

  • Yantai Yuhuangding Hospital

    Yantai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.