RecruitingEarly Phase 1NCT05800405

Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

9 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether adding targeted radiation therapy (called bridging radiation) before a CAR T-cell infusion improves outcomes for patients with large B-cell lymphoma that has come back or stopped responding to treatment. CAR T-cell therapy is a type of immunotherapy where your own immune cells are modified to fight cancer. **You may be eligible if:** - You are 18 or older - You have large B-cell lymphoma that has relapsed or is no longer responding to treatment - You are already planned to receive commercial CAR T-cell therapy within 3 months - You have 6 or fewer areas of active disease that can be targeted with radiation - You have measurable disease on imaging **You may NOT be eligible if:** - You have previously received CD19-directed therapy - You received radiation therapy in the last 21 days - Cancer has spread to the brain or spinal cord - You have an active serious infection - You have active diarrhea or another uncontrolled illness - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALChimeric Antigen Receptor T-Cell Therapy

Receive CAR-T per standard of care

PROCEDUREComputed Tomography

Undergo PET/CT

RADIATIONExternal Beam Radiation Therapy

Undergo radiation therapy

PROCEDURELeukapheresis

Receive leukapheresis

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05800405


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