Epcoritamab for Marginal Zone Lymphoma

Overseen By Izidore Lossos, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Izidore Lossos, MD

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: DLBCL transformation, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, it does mention that treatment with systemic immunosuppressive medications should be stopped 2 weeks before starting the trial, and corticosteroids should be reduced to a dose level of 20 mg/day or less within 7 days of starting the trial.

Is Epcoritamab safe for humans?

Epcoritamab has been tested in patients with certain types of lymphoma and has shown a manageable safety profile. Common side effects include cytokine release syndrome (a reaction that can cause fever and flu-like symptoms), injection-site reactions, infections, and low white blood cell counts, but these were mostly mild and resolved without stopping treatment. ^{1 2 3 4 5}

How does the drug Epcoritamab differ from other treatments for marginal zone lymphoma?

Epcoritamab is unique because it is a novel agent that targets specific pathways involved in the growth of lymphoma cells, potentially offering a new approach for treating marginal zone lymphoma, which currently lacks a standard treatment. This drug may provide an alternative to existing therapies that are often borrowed from treatments for other types of indolent lymphomas. ^{6 7 8 9 10}

Research Team

Izidore Lossos, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for patients with a diagnosis of Marginal Zone Lymphoma (MZL), which includes different subtypes like Splenic, MALT, and Nodal MZL. Specific eligibility criteria are not provided.

Inclusion Criteria

Ability to comply with the trial protocol

Able and willing to sign the informed consent form (ICF)

I have a specific type of marginal zone lymphoma.

Exclusion Criteria

My condition has progressed to diffuse large B-cell lymphoma.

I have had brain lymphoma or cancer spread to the lining of my brain.

I am currently being treated for a long-term or active infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 12 cycles of Epcoritamab therapy, each cycle lasting 28 days

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Epcoritamab

Trial Overview The study is testing the effectiveness of Epcoritamab in treating newly diagnosed patients with Marginal Zone Lymphoma. It aims to determine if this investigational treatment can benefit those affected by MZL.

Participant Groups

Group I: Epcoritamab Group Experimental Treatment 1 Intervention

Participants will receive up to 12 cycles of Epcoritamab therapy, each cycle lasting 28 days. Total participation is up to 3 years.

Who Is Running the Clinical Trial?

Izidore Lossos, MD

Lead Sponsor

Trials

2

Recruited

60+

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

Genmab

Industry 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

Findings from Research

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 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, 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]

Marginal zone lymphoma (MZL) is often overlooked in clinical trials that focus on other types of indolent lymphomas, highlighting the need for more targeted research.

The study suggests that disease progression within 24 months is linked to worse outcomes in MZL patients, indicating that future research should evaluate the effectiveness of new treatments specifically for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A roadmap for clinical trial design in marginal zone lymphoma. Alderuccio, JP., Habermann, T., Kuker, R., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Epcoritamab: First Approval. [2023]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. [2023]

4. England 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. [2021]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A roadmap for clinical trial design in marginal zone lymphoma. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Marginal Zone Lymphoma: A Canadian Perspective. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of 487 patients with early-stage extra-nodal marginal zone lymphoma. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Treatments and Outcomes in Stage I Extranodal Marginal Zone Lymphoma in the United States. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effective management strategies for patients with marginal zone lymphoma. [2019]