New antibody tested against aggressive blood cancer

NCT ID NCT05201248

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 ยท Last updated Sep 11, 2026

Summary

Researchers are testing an experimental drug called epcoritamab in Chinese adults with B-cell non-Hodgkin lymphoma. The trial gives epcoritamab alone or combines it with standard chemotherapy drugs (R-CHOP or R2). The main goals are to check safety and see how well the cancer responds to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epcoritamab, alone or combined with standard lymphoma drugs
What this could lead to
If it works, this could offer Chinese patients with B-cell lymphoma a new option, either alone or added to standard treatment.
What could go wrong
This is an early-phase trial with about 49 participants, so it may not show clear benefit or could cause side effects that limit its use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

49 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Sep 2026

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.

Inclusion Criteria: All Cohorts: * Life expectancy of \>= 3 months on standard of care (SOC). * Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2. * Has one or more measurable disease sites: * Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites. * \>= 1 measurable nodal lesion (long axis \> 1.5 cm and short axis \> 1.0 cm) or \>= 1.0 measurable extra-nodal lesion (long axis \>= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable. Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria: * Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 (or later) classification. * Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. * Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (\<6 months) of completion of therapy. Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria: * Must have histologically confirmed CD20+ DLBCL at most recent (previous or current) representative tumor biopsy based on the pathology report, inclusive of the following according to the World Health Organization (WHO) 2016 (or later) classification. * DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or. * "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible. * FL Grade 3B. * Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participants must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After safety run-in confirms tolerability of the full dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies. * Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment. * Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (\< 6 months) of completion of therapy. Cohort 2 Specific Criteria: * Must have newly diagnosed CD20+ DLBCL. * Must have one of the following histologically confirmed CD20+ DLBCL (de novo or histologically transformed from FL at most recent (previous or current) representative tumor biopsy based on the pathology report including one of the following diagnoses according to the WHO 2016 (or later) classification: * DLBCL, not otherwise specified (NOS); * "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations) Note: Double-/triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible or; * FL Grade 3B * Eligible for standard R-CHOP for 6 cycles. Cohort 3 Specific Criteria: * Must have histologically confirmed CD20+ Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and based on the pathology report, according to the WHO 2016 (or later) classification. * Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (\< 6 months) of completion of therapy. * Must be eligible for R2 per investigator determination. * Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only). Exclusion Criteria: All Cohorts: * History of primary mediastinal lymphoma. * Autologous Stem Cell Transplantation within 100 days prior to enrollment. * Have received prior allogeneic hematopoietic stem cell transplantation at any time. * Have been treated with a bispecific antibody targeting CD3 and CD20. Cohort 2 Specific Criteria: \- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Fujian Medical University Union Hospital /ID# 231890

    Fuzhou, Fujian, 350001, China

  • Guangdong Provincial People's Hospital /ID# 228028

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital /ID# 228772

    Zhengzhou, Henan, 450008, China

  • Hunan Cancer Hospital /ID# 231859

    Changsha, Hunan, 410006, China

  • Jiangxi Provincial Cancer Hospital /ID# 231944

    Nanchang, Jiangxi, 330029, China

  • Nanfang Hospital of Southern Medical University /ID# 227916

    Guangzhou, Guangdong, 510515, China

  • Peking University Third Hospital /ID# 228138

    Beijing, Beijing Municipality, 100191, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724

    Shanghai, Shanghai Municipality, 200065, China

  • Sun Yat-Sen University Cancer Center /ID# 228033

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Xuzhou Medical College /ID# 228774

    Xuzhou, Jiangsu, 221006, China

  • The Fifth Medical Center of PLA General Hospital /ID# 230520

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital of Nanchang University /ID# 228771

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University /ID# 228024

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154

    Hangzhou, Zhejiang, 310003, China

  • Tianjin Cancer Hospital /ID# 228135

    Tianjin, Tianjin Municipality, 300000, China

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University /ID# 231434

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer hospital /ID# 228776

    Hangzhou, Zhejiang, 310022, China

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