Trials / Recruiting

RecruitingNCT06784726

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 27 (estimated)

Sponsor: University of Washington · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients receive odronextamab intravenously (IV) on days 1, 2, 8, 9, 15 and 16 of cycle 1 (dose step-up), and on days 1, 8 and 15 of cycles 2-4 and then once every other week of remaining cycles. Cycles repeat every 21 days for the first 4 cycles, then every other week for up to a total of 12 months (including the first 2 cycles). After 2 cycles, patients undergo leukapheresis followed by lymphodepletion and CAR-T infusion per standard of care. If there is a significant delay of leukapheresis, patients may receive up to 12 additional weeks of treatment. Patients who achieve CR after cycle 2 may opt out of leukapheresis and CAR-T cell infusion and may continue to receive odronextamab in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)/computed tomography (CT), collection of blood and oral or rectal swab samples and tissue biopsy throughout the study. Additionally, patients may undergo lumbar puncture and bone marrow aspiration and/or biopsy on study. After completion of study treatment, patients are followed till 90 days or the initiation of the next lymphoma directed therapy for toxicity check, and total duration of follow-up is up to 5 years.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2025-09-04
Primary completion: 2028-04-10
Completion: 2033-04-11
First posted: 2025-01-20
Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06784726. Inclusion in this directory is not an endorsement.