RecruitingPhase 1NCT05371132

Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)

Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)


Sponsor

City of Hope Medical Center

Enrollment

10 participants

Start Date

Jun 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

"This phase I trial investigates the effect of radiation therapy on the immune system, specifically CD8 positive (+) T cells, in lymphoma patients receiving bridging radiation therapy before CAR T-cell infusion, and metastatic patients with solid tumor malignancies receiving SBRT. CD8+ T cells are mainly found in lymph tissue and play a significant role in anti-tumor immunity. These cells can infiltrate tumor cells and kill them. Radiation therapy may recruit CD8 T cells and this recruitment may help with tumor control. Diagnostic procedures, such as zirconium Zr 89-Df-crefmirlimab positron emission tomography (PET), may be a less invasive way to check and monitor for CD8+ T cells before and after radiation therapy."


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special PET scan using a tracer that targets CD8+ immune cells (a key type of immune fighter) can show how well the immune system responds to stereotactic body radiation therapy (SBRT — a precise, high-dose radiation treatment) in cancer patients. The scan may help doctors predict which patients will respond to immunotherapy. **You may be eligible if...** - You are 18 or older - You have metastatic (spread) cancer of any solid tumor type that is suitable for SBRT radiation treatment - You are in reasonably good health (ECOG 0–2) - Your cancer treatment regimen has been stable for the past 2 months - You can come in daily for PET scans after radiation **You may NOT be eligible if...** - You have a spleen disorder or have had your spleen removed in a way that would interfere with imaging - You have an uncontrolled infection or illness - You are allergic to the CD8 PET imaging agent - You are pregnant or breastfeeding 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

PROCEDUREPositron Emission Tomography

Undergo PET

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

DRUGZirconium Zr 89-Df-Crefmirlimab

Given IV

RADIATIONIntensity Modulated Radiation Therapy

IMRT for Lymphoma patients only


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05371132


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