New antibody tested against aggressive blood cancer
NCT ID NCT05201248
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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49 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fujian Medical University Union Hospital /ID# 231890
Fuzhou, Fujian, 350001, China
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Guangdong Provincial People's Hospital /ID# 228028
Guangzhou, Guangdong, 510080, China
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Henan Cancer Hospital /ID# 228772
Zhengzhou, Henan, 450008, China
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Hunan Cancer Hospital /ID# 231859
Changsha, Hunan, 410006, China
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Jiangxi Provincial Cancer Hospital /ID# 231944
Nanchang, Jiangxi, 330029, China
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Nanfang Hospital of Southern Medical University /ID# 227916
Guangzhou, Guangdong, 510515, China
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Peking University Third Hospital /ID# 228138
Beijing, Beijing Municipality, 100191, China
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
Shanghai, Shanghai Municipality, 200065, China
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Sun Yat-Sen University Cancer Center /ID# 228033
Guangzhou, Guangdong, 510060, China
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The Affiliated Hospital of Xuzhou Medical College /ID# 228774
Xuzhou, Jiangsu, 221006, China
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The Fifth Medical Center of PLA General Hospital /ID# 230520
Beijing, Beijing Municipality, 100071, China
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The First Affiliated Hospital of Nanchang University /ID# 228771
Nanchang, Jiangxi, 330006, China
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The First Affiliated Hospital of Soochow University /ID# 228024
Suzhou, Jiangsu, 215006, China
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The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
Hangzhou, Zhejiang, 310003, China
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Tianjin Cancer Hospital /ID# 228135
Tianjin, Tianjin Municipality, 300000, China
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Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
Wuhan, Hubei, 430022, China
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West China Hospital, Sichuan University /ID# 231434
Chengdu, Sichuan, 610041, China
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Zhejiang Cancer hospital /ID# 228776
Hangzhou, Zhejiang, 310022, China
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