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

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.

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent Grade 3b Follicular Lymphoma
• Recurrent High Grade B-Cell Lymphoma
• Recurrent Primary Mediastinal Large B-Cell Lymphoma
• Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory Grade 3b Follicular Lymphoma
• Refractory High Grade B-Cell Lymphoma
• Refractory Primary Mediastinal Large B-Cell Lymphoma
• Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

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 Procedure

Undergo tissue biopsy

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Mengyang Di, MD, PhD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-04

Primary Completion

2028-04-10

Completion

2033-04-11

FDA Drug

Yes

Countries

• United States

Study Locations