Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05371132

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

Led by City of Hope Medical Center · Updated on 2026-01-28

10

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

"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."

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent
  • Willing and able to follow all study procedures
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
  • Metastatic solid tumor cancer suitable for SBRT as determined by radiation oncologist
  • Lymphoma patients allowed as determined by the principal investigator
  • No changes in systemic cancer treatment for at least 2 months before starting SBRT
  • Able to comply with daily PET scans after SBRT
  • Meets clinical safety lab values per institution standards or investigator's discretion
  • Negative pregnancy test for women of childbearing potential
  • Agreement by males and females of childbearing potential to use effective double barrier contraception or abstain from heterosexual activity during the study and for 30 days after last CD8 PET tracer dose
  • Childbearing potential defined as not surgically sterilized or not free from menses for more than 1 year (women only)
Not Eligible

You will not qualify if you...

  • Splenic disorders or prior splenectomy that interferes with CD8 imaging
  • Uncontrolled illness or active infection
  • History of allergic reactions to similar compounds as CD8 PET tracer
  • Serious nonmalignant diseases or conditions compromising study goals
  • Pregnant or breastfeeding women
  • Any condition that contraindicates participation due to safety concerns
  • Inability to comply with study procedures as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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