Epcoritamab for Lymphoma

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Academic and Community Cancer Research United

Must not be taking: CD20 antibodies

Disqualifiers: Bulky disease, CNS lymphoma, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 91

Duration: 12 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called epcoritamab for individuals with B-cell lymphoma who haven't fully improved after CAR-T therapy. Epcoritamab aims to help the immune system target and kill cancer cells more effectively. Participants will either receive epcoritamab or be under observation to compare results. This trial may suit those with B-cell lymphoma who haven't achieved complete remission following specific CAR-T therapies and still have measurable disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have received a CD20-targeted monoclonal antibody within 4 weeks prior to registration.

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

Research has shown that epcoritamab may effectively treat B-cell lymphomas. In one study involving patients with diffuse large B-cell lymphoma (DLBCL), 148 participants received epcoritamab, and 61% went into remission. Of these, 38% experienced complete remission, meaning all signs of their cancer disappeared.

Regarding safety, patients who previously took epcoritamab reported some side effects. The most common were fever, tiredness, and reactions at the injection site. These side effects were usually mild and manageable.

This trial is in Phase 2, indicating that the treatment has shown initial safety in humans, but researchers continue to monitor its effects closely to ensure safety. Epcoritamab is also being compared to standard observation, so evaluating its safety and effectiveness in these patients remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lymphoma?

Epcoritamab is unique because it targets CD3 and CD20 proteins, which are found on the surface of certain immune and lymphoma cells. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, epcoritamab is a type of immunotherapy designed to engage the body's own immune system to specifically target and destroy lymphoma cells. This targeted action not only holds the potential for greater efficacy but also may result in fewer side effects compared to more conventional treatments. Researchers are particularly excited about epcoritamab's subcutaneous delivery method, which offers more convenience and potentially better patient adherence than intravenous options.

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

Research has shown that epcoritamab, which participants in this trial may receive, offers promising results for treating B-cell lymphomas. In one study with patients who had aggressive forms of this cancer, about 80% responded to the treatment. Another study with 148 patients found that 61% went into remission, with 38% achieving complete remission. Among those with follicular lymphoma, 60% reached complete remission, and 82% responded to the treatment. These findings suggest that epcoritamab may help patients achieve remission after other treatments have been tried. ^{1 2 4 6 7}

Who Is on the Research Team?

Grzegorz S Nowakowski

Principal Investigator

Academic and Community Cancer Research United

Are You a Good Fit for This Trial?

This trial is for patients with B-cell lymphomas who haven't fully recovered after CD19-directed CAR-T therapy. Participants should have had a partial response or stable disease post-treatment, but not complete remission.

Inclusion Criteria

My disease can be measured with tests.

I received a specific CAR-T therapy and had a partial response after about a month.

I am willing to give tissue and blood samples for research.

Exclusion Criteria

I have received specific treatments before.

I have had CAR-T therapy and my cancer is still large.

Psychiatric illness/social situations limiting compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive epcoritamab subcutaneously on a specified schedule for up to 12 cycles, with MRI, PET/CT, and blood sample collection throughout the trial

12 months

Multiple visits (in-person) per cycle

Observation

Patients undergo observation per standard care, with MRI, PET/CT, and blood sample collection throughout the trial

12 months

Regular visits (in-person) per standard care

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 90 days for 1 year and then every 180 days for up to 5 years

5 years

Follow-up visits every 90 to 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Epcoritamab

Trial Overview The study compares epcoritamab, a bispecific antibody targeting cancerous B-cells and T-cells to enhance immune response, against standard observation after CAR-T therapy in achieving complete remission.

How Is the Trial Designed?

Group I: Arm A (epcoritamab) Experimental Treatment 6 Interventions

Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and day 1 of cycles 10-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.

Group II: Arm B (observation) Active Control 6 Interventions

Patients undergo observation per standard care. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.

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?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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, 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/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. 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 ...

3. epkinlyhcp.com epkinlyhcp.com/fl/clinical-trial-results

FL Clinical Trial Results - EPKINLY® (epcoritamab-bysp) ... 60% CR was observed in EPCORE® NHL-1 1-4. 82% of patients had a response (n equals 104 out of 127; 95% CI, 74 to 88), 60% of patients had a complete response.

4. 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 ... In patients treated with epcoritamab following two or more lines of systemic therapy (n=50), with a median follow-up of 10.8 months, the study ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588654/

Epcoritamab in relapsed/refractory large B-cell lymphoma At data cutoff, 27 patients (17.2%) continued receiving study treatment and 21 (13.4%) patients had received epcoritamab for at least 24 months.

6. epkinlyhcp.com epkinlyhcp.com/dlbcl/clinical-trial-results

DLBCL Clinical Trial Results - epkinly® hcp EPKINLY delivered an ORR of 61%, with 38% of patients achieving a deep response of CR 1. 61% of patients had a response (n=90/148; 95% CI, 53-69).

7. 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 safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more ...