Epcoritamab for B-Cell Lymphoma

(EPCORE™ NHL-1 Trial)

Not currently recruiting at 101 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must be taking: Anti-CD20 antibodies

Must not be taking: Steroids, Anti-epileptics

Disqualifiers: CNS lymphoma, Cardiovascular disease, Autoimmune, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new antibody treatment called epcoritamab for individuals with certain types of B-cell lymphoma that have returned or resisted previous treatments. The trial aims to determine the optimal dose, understand side effects, and assess how the body processes and responds to the treatment. Suitable candidates have B-cell lymphoma that hasn't improved with other therapies, including those who have undergone unsuccessful stem cell transplants. Participants will receive the treatment through injections and will be monitored for up to 1.5 years, with frequent site visits. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

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, a type of blood cancer. These studies carefully examined the treatment's safety. Cytokine release syndrome (CRS) occurred in 51% of patients, with most cases being mild to moderate and only 2.5% severe. Other common side effects include tiredness, muscle and bone pain, injection site reactions, and fever.

The FDA has approved epcoritamab for treating a type of B-cell lymphoma, indicating it meets certain safety standards. However, close monitoring remains important, especially after the first doses, to quickly manage any side effects. Overall, while side effects exist, many are manageable, and the treatment is considered safe enough for further research and use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Epcoritamab is unique because it introduces a new way to treat B-cell lymphoma by harnessing the power of the immune system. Unlike traditional chemotherapy or targeted therapies, Epcoritamab is a bispecific antibody that engages both T-cells and cancer cells, prompting the immune system to attack the lymphoma cells directly. This innovative mechanism of action offers the potential for more precise targeting of cancer cells while sparing healthy ones, which might lead to fewer side effects. Researchers are excited about Epcoritamab because it is administered subcutaneously, potentially allowing for more convenient dosing compared to intravenous infusions.

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, has promising effects in treating relapsed and refractory B-cell lymphoma. In one study, 64.3% of patients responded to the treatment, with 47.6% experiencing a complete response, meaning their cancer was undetectable. Another study found that 61% of patients went into remission, with 38% achieving complete remission. Epcoritamab also demonstrated better results compared to other treatments, such as CIT and polatuzumab-based regimens. These studies suggest that epcoritamab could be an effective option for those fighting this type of lymphoma. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with various types of B-cell lymphoma that have relapsed or didn't respond to previous treatments, including an anti-CD20 monoclonal antibody. Participants should be in a stable condition (ECOG 0,1,2), have measurable disease and proper kidney and liver function. Those with CNS lymphoma involvement, other cancers, significant heart conditions, immune diseases requiring suppression therapy, recent CAR-T therapy or stem cell transplant are excluded.

Inclusion Criteria

I'm sorry, but I'm unable to understand what "FL" stands for in this context. Could you please provide more information or clarify?

I have been diagnosed with small lymphocytic lymphoma (SLL).

Patients must have measurable disease by CT, MRI or PET-CT scan

Exclusion Criteria

I have previously been treated with a specific experimental drug for my condition.

I have not had CAR-T therapy in the last 30 days.

I am eligible for a high-intensity treatment plan aimed at curing my cancer, followed by stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Dose-Escalation

Participants receive epcoritamab to determine the maximum tolerated dose and establish the safety profile

6 months

Daily or every few days for the first month, then weekly

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Expansion

Additional participants are treated with epcoritamab at the recommended Phase 2 dose to further explore safety and efficacy

1 year

Weekly, every other week, once a month, and once every 2 months

Dose-Optimization

Evaluation of alternative priming and intermediate dose regimens of epcoritamab

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Epcoritamab

Trial Overview Epcoritamab (EPKINLY™/GEN3013) is being tested in this multi-phase trial to determine its safety and effectiveness against B-cell lymphomas. The study includes dose-escalation to find the right amount of drug needed (Phase 1), expansion to treat more patients at that dose (Phase 2a), and optimization to refine dosing further (Phase 2a).

How Is the Trial Designed?

Group I: Epcoritamab Experimental Treatment 1 Intervention

Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.

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

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]

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]

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-B

Real-world outcomes of patients with aggressive B-cell ... A total of 201 of 245 patients (82.0%) were efficacy-evaluable (124 treated with epcoritamab [80%], and 77 treated with glofitamab [87%]).

2. 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, ...

3. 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 ...

4. 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%.

5. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-024-01594-x

Comparisons of treatment outcomes of epcoritamab versus ... In this analysis, epcoritamab demonstrated significantly better response rates and overall survival rates than CIT, polatuzumab-based regimens, and tafasitamab ...

6. epkinlyhcp.com epkinlyhcp.com/important-safety-information

Important Safety Information CRS occurred in 51% of patients with large B-cell lymphoma (LBCL) in the clinical trial (37% grade 1, 17% grade 2, and 2.5% grade 3) and recurred in 16% of ...

7. epkinly.com epkinly.com/

EPKINLY® for 3L+ DLBCL and FL In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf

EPKINLY (epcoritamab-bysp) injection - accessdata.fda.gov EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large. B-cell lymphoma (DLBCL), not otherwise specified, including ...

9. ema.europa.eu ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf

Tepkinly, INN-epcoritamab - EMA The safety of epcoritamab was evaluated in a non-randomised, single-arm GCT3013-01 study in 382 patients with relapsed or refractory large B-cell lymphoma (N= ...

10. epkinlyhcp.com epkinlyhcp.com/

EPKINLY® (epcoritamab-bysp) for DLBCL and FL - Official ... Patients with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours following administration of the first full 48 mg dose. Monitor patients ...