Epcoritamab + Chemotherapy for Diffuse Large B-Cell Lymphoma

Overseen By Selina Laqui

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must not be taking: Bispecific T-cell engagers

Disqualifiers: Active infections, CNS involvement, 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

Compensation: Varies

Number of Visits: 14

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining epcoritamab with standard chemotherapy and a stem cell transplant can more effectively treat patients with large B-cell lymphoma that has returned or resisted previous treatments. Epcoritamab helps the immune system target and destroy cancer cells. Ideal participants have large B-cell lymphoma that has relapsed or not responded to initial treatment and are eligible for platinum-based chemotherapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use other anti-cancer treatments or investigational drugs close to starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that epcoritamab is generally well-tolerated by people with relapsed or refractory large B-cell lymphoma. In studies, some patients experienced side effects common with cancer treatments, such as fever, tiredness, and injection site reactions. However, these side effects were usually manageable and did not require stopping the treatment.

Epcoritamab has already received approval in the United States for treating similar types of lymphoma, indicating a known safety profile. When combined with standard chemotherapy in this trial, the goal is to enhance its effectiveness against cancer cells without significantly increasing side effects. Patients should always consult their doctor about potential risks to understand how this treatment might work for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Epcoritamab is unique because it is a bispecific antibody, meaning it can engage both T-cells and cancer cells simultaneously to help the immune system target and destroy cancer more effectively. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, Epcoritamab specifically targets the CD20 protein found on B-cell lymphomas, potentially leading to fewer side effects. Researchers are excited about Epcoritamab because it could offer a more precise and powerful approach to treating diffuse large B-cell lymphoma, especially for patients who may not respond well to existing treatment options like R-CHOP.

What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?

Research has shown that epcoritamab yields promising results for treating diffuse large B-cell lymphoma (DLBCL), particularly when the cancer returns or resists other treatments. In one study, 64.3% of patients responded to epcoritamab, with 47.6% showing no detectable cancer after an average of 5.8 months. Another study reported similar outcomes, with 56% of patients responding and 47% having no detectable cancer. Epcoritamab aids the immune system in targeting and destroying cancer cells. This trial will assess the effectiveness of combining epcoritamab with standard chemotherapy for DLBCL that has recurred or is difficult to treat, potentially offering a valuable addition to existing treatment options. ^{1 4 6 7 8}

Who Is on the Research Team?

Joseph M Tuscano

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for patients with large B-cell lymphoma that has either returned after treatment (relapsed) or hasn't responded to previous treatments (refractory). Participants should have a type of lymphoma that can potentially respond to the drugs being tested. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the stage of cancer.

Inclusion Criteria

Measurable disease via diagnostic quality CT or PET/CT

ALT ≤ 3 x ULN

AST ≤ 3 x ULN

Exclusion Criteria

My cancer has spread to my brain or its coverings.

I have a confirmed autoimmune disease.

Known history of seropositivity for HIV infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-AutoHCT Treatment

Participants receive epcoritamab subcutaneously and SOC platinum-based chemotherapy for up to 3 cycles

12 weeks

4 visits per cycle (in-person)

AutoHCT

Participants undergo autologous hematopoietic cell transplantation

1 week

1 visit (in-person)

Post-AutoHCT/Consolidation

Participants receive epcoritamab for up to 12 cycles post-transplant

48 weeks

4 visits per cycle initially, then reduced frequency

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Epcoritamab
• Oxaliplatin

Trial Overview The trial is testing epcoritamab combined with standard platinum-based chemotherapy (like RICE or Gem/Ox) and autologous hematopoietic cell transplant. Epcoritamab is designed to help the immune system target and kill lymphoma cells by binding to specific proteins on T cells and B cells.

How Is the Trial Designed?

Group I: Treatment (epcoritamab, SOC chemotherapy, autoHCT) Experimental Treatment 11 Interventions

See Detailed Description

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Joseph Tuscano

Lead Sponsor

Trials

8

Recruited

180+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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, 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, 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, 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 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]

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. 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 ... ... diffuse large B-cell lymphoma (DLBCL) in an outpatient setting; Results showed that 92% of patients with R/R DLBCL received the first full ...

3. 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%.

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 ... 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, ...

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

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04663347

NCT04663347 | Safety and Efficacy Trial of Epcoritamab ... The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, ...

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

Safety and Efficacy of Epcoritamab in Relapsed, Refractory ... In this meta-analysis, we evaluated the efficacy and safety of epcoritamab in relapsed, refractory B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [ ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.01725

Epcoritamab, a Novel, Subcutaneous CD3xCD20 ... Outcomes are poor for patients with relapsed or refractory large B-cell lymphoma (LBCL). This study evaluated the efficacy and safety of ...