RecruitingPhase 2NCT06784726

Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T

Odronextamab for Relapsed/Refractory Large B-cell Lymphomas Before Definitive Lymphoma-Directed Therapies


Sponsor

University of Washington

Enrollment

27 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called odronextamab — an antibody that targets cancer cells — as a "bridge" treatment to prepare patients with large B-cell lymphoma (a type of blood cancer) for CAR-T cell therapy. The goal is to control the cancer while patients wait for their CAR-T cells to be prepared. **You may be eligible if...** - You have been diagnosed with large B-cell lymphoma (such as DLBCL, follicular lymphoma Grade 3B, or related types) - Your lymphoma has returned or stopped responding to at least one prior treatment - You have at least one measurable tumor on imaging - You are being considered for CAR-T cell therapy **You may NOT be eligible if...** - You have a different type of lymphoma not listed in the study - You do not have measurable disease on scans - You have major organ problems that would prevent treatment 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

BIOLOGICALOdronextamab

Given IV

PROCEDUREBiospecimen Collection

Undergo collection of blood and oral or rectal swab samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

BIOLOGICALChimeric Antigen Receptor T-Cell Therapy

Undergo CAR-T cell therapy

PROCEDUREComputed Tomography

Undergo PET/CT

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREBiopsy

Undergo tissue biopsy


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06784726


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