Epcoritamab + Ibrutinib for Non-Hodgkin's Lymphoma

Recruiting at1 trial location

Overseen by Yazeed Sawalha

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Yazeed Sawalha

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

Research Team

Yazeed Sawalha

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for people with aggressive B-cell non-Hodgkin lymphoma that has returned or hasn't responded to treatment. Participants should have a type of lymphoma that the drugs used in this study are designed to target.

Inclusion Criteria

My cancer can be measured or shows up on a PET scan.

Satisfactory blood counts (ANC ≥ 1,000/mcL, Platelet count ≥ 75,000/mcL, Hemoglobin ≥ 8 g/dL)

Ability to understand and sign informed consent documents

Exclusion Criteria

Serious medical or psychiatric illnesses

Known allergies to study medications

I have not had a stroke or brain bleed recently.

Treatment Details

Interventions

• Epcoritamab (Monoclonal Antibodies)
• Ibrutinib (Kinase Inhibitor)

Trial Overview The trial tests epcoritamab combined with ibrutinib on patients. Epcoritamab is an antibody that helps immune cells attack lymphoma, and ibrutinib blocks a protein helping these cancer cells grow.

Participant Groups

Group I: Treatment (epcoritamab, ibrutinib) Experimental Treatment 7 Interventions

Patients receive ibrutinib PO QD on days -7 to 28 of cycle 1 and on days 1 to 28 of remaining cycles, as well as epcoritamab SC on days 1, 8, 15 and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and on day 1 of remaining cycles. Treatment repeats every 28 days for up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and PET/CT throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.

Who Is Running the Clinical Trial?

Yazeed Sawalha

Lead Sponsor

Trials

3

Recruited

60+

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

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