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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06784726
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Odronextamab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and oral or rectal swab samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Chimeric Antigen Receptor T-Cell Therapy — BIOLOGICAL
    Undergo CAR-T cell therapy
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy

Study Details

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.

Key Dates

Start date
Sep 4, 2025
Status verified
May 2026
Primary completion
Apr 10, 2028
Completion
Apr 11, 2033

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (odronextamab)
    Patients receive odronextamab IV based on the following schedules: * Step-up dosing during cycle 1: 0.2 mg on C1D1, 0.5 mg on C1D2, 2 mg on C1D8 and C1D9, respectively, and 10 mg on C1D15 and C1D16, respectively (0.7/4/20 regimen). * Dosing during cycles 2-4: Odron will be given at 160 mg weekly. * Once every other week at 320 mg of remaining cycles. Please see the Detailed Description for additional information.

Primary Outcome Measure

Failure to undergo leukapheresis [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Mengyang Di, MD, PhD
[email protected]
206-606-2509
Mengyang Di, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

Related Studies