Epcoritamab for B-Cell Lymphoma

Not currently recruiting at 74 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genmab

Must not be taking: Chemotherapy, Radiotherapy, Monoclonal antibodies, others

Disqualifiers: CNS involvement, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 37 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new drug, epcoritamab, for treating aggressive B-cell lymphomas in children and young adults. It targets patients whose cancer has returned or hasn't responded to other treatments. Participants should have a diagnosis of relapsed or difficult-to-treat B-cell lymphoma after previous treatments. The trial requires regular hospital visits to monitor the drug's effects and manage any side effects. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot be receiving any anti-cancer therapy, including chemotherapy, radiotherapy, or other investigational agents, while participating.

Is there any evidence suggesting that epcoritamab is likely to be safe for humans?

Research has shown that epcoritamab has been tested in people with B-cell lymphoma, yielding promising results. In one study, 82% of patients experienced significant cancer reduction or disappearance, suggesting the treatment's effectiveness.

Regarding safety, studies indicate that epcoritamab can be administered safely outside of a hospital setting. This suggests it is generally well-tolerated and does not require constant hospital monitoring. Another study with 36 patients over about three years found the treatment to be safe and effective.

It is important to note that while these results are positive, the current trial is in an early phase. Researchers are still assessing its safety in children and young adults. Epcoritamab is being tested to evaluate patient tolerance and monitor any side effects. So far, previous studies suggest it is tolerable, but more information is needed to confirm this in younger populations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for B-cell lymphoma, like chemotherapy and targeted therapies, work by attacking cancer cells directly or blocking specific proteins. But epcoritamab works differently. It’s a bispecific antibody that brings T-cells, a type of immune cell, directly to the cancer cells, helping the body’s own immune system attack the lymphoma more effectively. Researchers are excited about epcoritamab because it offers a new way to engage the immune system in fighting the cancer, potentially leading to better outcomes for patients with this condition. Plus, it's delivered as a subcutaneous injection, which could be more convenient compared to traditional intravenous methods.

What evidence suggests that epcoritamab might be an effective treatment for B-cell lymphoma?

Research has shown that epcoritamab, the treatment under study in this trial, may benefit patients with aggressive B-cell lymphomas. In one study, 64.3% of patients responded positively to the treatment, with 47.6% achieving complete remission, meaning no signs of cancer were found. Another study found that 61% of patients went into remission, with 38% achieving complete remission. These results are promising, especially for those whose lymphoma has returned or is difficult to treat. Epcoritamab targets specific proteins on cancer cells, helping the immune system find and attack these cells more effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for children and young adults (up to age 25) with aggressive B-cell lymphomas that haven't responded well to previous treatments. They should be able to perform daily activities at a certain level, have no other cancers needing treatment, and not currently be on anti-cancer therapies.

Inclusion Criteria

I have recovered from the side effects of my previous cancer treatment.

I can do most activities but may need help.

Disease pathologically confirmed (tumor tissue) by local testing.

Exclusion Criteria

I am currently undergoing treatment for cancer.

My lymphoma has spread to my brain or spinal cord, confirmed by scans.

I am receiving treatment for another cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous epcoritamab in 28-day cycles

Up to 37 weeks

Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Epcoritamab

Trial Overview

The study tests Epcoritamab's safety and effects in patients with relapsed/refractory mature B-cell neoplasms. Participants will receive the drug through subcutaneous injections over cycles of 28 days and will be monitored for at least three years.

How Is the Trial Designed?

Group I: Epcoritamab Experimental Treatment 1 Intervention

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Epcoritamab is already approved in United States, European Union for the following indications:

Approved in United States as Epkinly for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
• Diffuse large B-cell lymphoma after two or more lines of systemic therapy

Approved in European Union as Tepkinly for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
• Relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

The combination of pembrolizumab and vorinostat was found to be tolerable in patients with relapsed/refractory B-cell lymphomas, although there were serious adverse events, including one case of Stevens-Johnson syndrome that led to a fatal infection.

The treatment showed promising efficacy, especially in primary mediastinal B-cell lymphoma (PMBL), with a complete response rate of 80% and overall response rate of 80%, while overall response rates for other non-PMBL diffuse large B-cell lymphoma (DLBCL) were lower at 33%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a phase I trial of pembrolizumab plus vorinostat in relapsed/refractory B-cell non-Hodgkin lymphoma. Godfrey, J., Mei, M., Chen, L., et al.[2023]

Epcoritamab is a bispecific antibody that targets CD3 and CD20, designed for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and received conditional approval in the USA on May 19, 2023, for adult patients after at least two prior therapies.

The drug has also received a positive opinion in the EU and is under review in Japan, indicating its potential as a significant treatment option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epcoritamab: First Approval. Frampton, JE.[2023]

Epcoritamab, a bispecific antibody targeting CD3 and CD20, was found to be safe and well-tolerated in 73 patients with relapsed or refractory B-cell non-Hodgkin lymphoma, with no dose-limiting toxic effects and a recommended phase 2 dose established at 48 mg.

The treatment showed promising efficacy, with an overall response rate of 68% in patients with diffuse large B-cell lymphoma and 90% in those with follicular lymphoma, indicating its potential as a viable therapy for these difficult-to-treat conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Hutchings, M., Mous, R., Clausen, MR., et al.[2021]

Epcoritamab, a bispecific antibody, showed strong efficacy in killing primary tumor cells from patients with newly diagnosed and relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), achieving median lysis rates of 65% to 84% across different lymphoma types.

The effectiveness of epcoritamab was consistent regardless of prior treatments, including CD20 monoclonal antibodies, indicating its potential as a treatment option for patients who have become resistant to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. van der Horst, HJ., de Jonge, AV., Hiemstra, IH., et al.[2021]

Epcoritamab, a bispecific antibody targeting CD3 and CD20, demonstrated a 55.6% overall response rate and a 44.4% complete response rate in 36 Japanese patients with relapsed or refractory CD20+ B-cell non-Hodgkin's lymphoma after a median follow-up of 8.4 months.

The treatment had a manageable safety profile, with cytokine release syndrome being the most common adverse event (83.3%), primarily low grade, and all cases resolved without leading to treatment discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Izutsu, K., Kumode, T., Yuda, J., et al.[2023]

Epcoritamab, a bispecific antibody targeting CD3 and CD20, showed a 63.1% overall response rate in 157 patients with relapsed or refractory large B-cell lymphoma, indicating its efficacy in this challenging patient population.

The treatment was generally well-tolerated, with manageable side effects; however, cytokine release syndrome was common (49.7%), and there was one reported fatality due to immune effector cell-associated neurotoxicity syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. Thieblemont, C., Phillips, T., Ghesquieres, H., et al.[2023]

Citations

1.

ashpublications.org

ashpublications.org/blood/article/doi/10.1182/blood.2025029117/546196/Real-world-outcomes-of-patients-with-aggressive-B

Real-world outcomes of patients with aggressive B-cell ...

Epcoritamab and glofitamab had an ORR and CRR of 51.7% and 25.4%, respectively; median PFS was 2.5 months, and median OS was 7.8 months.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12296760/

3-year follow-up from the EPCORE NHL-3 trial

As of July 12, 2024, 36 patients received epcoritamab (median follow-up, 36.7 months). Overall/complete response rates were 56%/47%. Median ...

3.

news.abbvie.com

news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL

AbbVie Announces Updated Results From Phase 2 ...

The study also showed an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow-up of 5.8 months, ...

4.

epkinly.com

epkinly.com/clinical-trial-results

Clinical Trial Results - EPKINLY® (epcoritamab-bysp)

DLBCL: In a clinical study of 148 patients receiving EPKINLY, 61% (90 patients) achieved remission: complete remission in 38% (56 patients) and partial ...

5.

ir.genmab.com

ir.genmab.com/news-releases/news-release-details/genmab-announces-updated-results-phase-2-epcorer-nhl-6-study

Genmab Announces Updated Results from Phase 2 ...

The study also demonstrated an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow up of 5.8 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40434509/

Efficacy and safety of epcoritamab in Japanese patients ...

Results: As of July 12, 2024, 36 patients received epcoritamab (median follow-up, 36.7 months). Overall/complete response rates were 56%/47%.

7.

nature.com

nature.com/articles/s41375-024-02410-8

Epcoritamab in relapsed/refractory large B-cell lymphoma

Findings in the present study of epcoritamab with median follow-up of 25.1 months were favorable, with median OS of 18.5 months. Further, to our ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2152265025023766

Safety and Efficacy of Epcoritamab in Relapsed, Refractory ...

Conclusions. Our study demonstrated pooled ORR of 73% in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, 71.7% for DLBCL and 82.5 ...