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RECRUITING
NCT06784726
PHASE2

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2025-09-04

Completion Date

2033-04-11

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Odronextamab

Given IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood and oral or rectal swab samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Undergo CAR-T cell therapy

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Biopsy

Undergo tissue biopsy

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States