RecruitingPhase 1Phase 2NCT06536049

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

Phase Ib/II Trial of Epcoritamab Plus Ibrutinib in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma


Sponsor

Yazeed Sawalha

Enrollment

38 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — epcoritamab (an immunotherapy) and ibrutinib (a targeted therapy) — in people with aggressive B-cell lymphoma (a type of blood cancer) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of aggressive B-cell lymphoma - Your lymphoma has returned or stopped responding after at least 2 prior treatments - You are in reasonable health and your blood counts and organ function meet minimum thresholds - You have not previously received a bispecific antibody targeting CD3 and CD20 **You may NOT be eligible if...** - You have lymphoma involving the brain or spinal cord - You have serious heart conditions such as recent heart attack or severe heart failure - You have a history of intracranial bleeding - You are on blood thinners like warfarin - You are pregnant or breastfeeding - You have active HIV or hepatitis B/C infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT and PET/CT

BIOLOGICALEpcoritamab

Given SC

DRUGIbrutinib

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(2)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06536049


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