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Feasibility of Low Dose Radiation as Bridging Therapy for Lisocabtagene Maraleucel in Relapsed B-Cell Non-Hodgkin Lymphoma
The goal of this clinical trial is to learn about treatment for people with B-cell lymphoma that did not respond to treatment or that has gotten worse after treatment. The aim of this trial is to answer the following questions: * If it is realistic to give people radiation treatment before they receive a chimeric antigen receptor (CAR) T-cell treatment for their cancer * If it is safe to give people radiation treatment before they receive a CAR T-cell treatment for their cancer
This is a pilot study to evaluate the feasibility of low-dose radiation therapy in the bridging period between chimeric antigen receptor (CAR) T-cell collection, manufacturing, and infusion (vein-to-vein) in patients with relapsed and refractory aggressive B-cell lymphoma. Emerging cellular immunotherapies including CAR T-cell therapy have produced remarkable outcomes for this population. The Food and Drug Administration (FDA) has recently approved lisocabtagene maraleucel (liso-cel) for the management of people with relapsed and refractory B-cell lymphoma. Unfortunately, many patients undergoing liso-cel infusion will suffer progression or relapse with devastating consequences. The object of this study is to identify a novel means to enhance liso-cel activity to improve overall outcomes. The investigators hypothesize that the addition of radiation therapy targeting selected sites as bridging therapy prior to lymphodepleting chemotherapy and liso-cel infusion will be effective at improving responses for patients with relapsed and refractory B-cell lymphoma. Results from this study will provide key justification to expand this therapeutic approach into a larger phase II clinical trial powered to examine the efficacy of this approach.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Nebraska Medical Center
Omaha, Nebraska, United States
Start Date
March 21, 2023
Primary Completion Date
January 20, 2025
Completion Date
September 1, 2027
Last Updated
September 25, 2025
33
ESTIMATED participants
Bridging radiation therapy
RADIATION
Liso-cel
BIOLOGICAL
Post-infusion radiation
RADIATION
Lead Sponsor
University of Nebraska
Collaborators
NCT06337318
NCT05006716
Data Source & Attribution
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