Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Summary

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.

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Grade 3b Follicular Lymphoma
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
• Recurrent Primary Mediastinal Large B-Cell Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Grade 3b Follicular Lymphoma
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
• Refractory Primary Mediastinal Large B-Cell Lymphoma
• Refractory Transformed Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Computed Tomography

Undergo CT and PET/CT

BIOLOGICAL

Epcoritamab

Given SC

DRUG

Ibrutinib

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Genmab

  collaborator INDUSTRY

• Yazeed Sawalha

  lead OTHER

Principal Investigators

• Yazeed Sawalha · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-02

Primary Completion

2026-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations