RecruitingPhase 1NCT06735664

Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation

A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation

Sponsor

City of Hope Medical Center

Enrollment

23 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Transformed Chronic Lymphocytic Leukemia Refractory Transformed Chronic Lymphocytic Leukemia Richter Syndrome Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma

Summary

This phase I trial tests the safety and side effects of zanubrutinib in combination with odronextamab and how well it works in treating patients with Richter's transformation. Zanubrutinib, a tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Odronextamab is a bispecific monoclonal antibody that can bind to two different antigens at the same time. Odronextamab binds to CD20 found on B-cells (a type of white blood cell) and on many B-cell cancers and to CD3 on T-cells (also a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving zanubrutinib in combination with odronextamab may be safe, tolerable and/or effective in treating patients with Richter's transformation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — zanubrutinib (a BTK inhibitor that blocks cancer cell growth signals) and odronextamab (a bispecific antibody that helps immune cells attack cancer) — for patients whose chronic lymphocytic leukemia (CLL) has transformed into an aggressive lymphoma called Richter's transformation. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with Richter's transformation — specifically the diffuse large B-cell lymphoma (DLBCL) subtype — confirmed by biopsy - Your cancer cells test positive for CD20 (a protein on the cell surface) - Your general health score (ECOG) is 2 or lower **You may NOT be eligible if...** - Your Richter's transformation is the Hodgkin lymphoma subtype - Your cancer cells do not express CD20 - You are in poor general health 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

PROCEDUREBiopsy

Undergo ultrasound guided biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo optional bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

BIOLOGICALOdronextamab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET

PROCEDUREUltrasound Imaging

Undergo ultrasound guided biopsy

DRUGZanubrutinib

Given PO

Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06735664

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