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ELIXR Study: CD8 PET Imaging for Immune Response to Radiation Therapy

This study, called ELIXR, is looking at how radiation therapy affects your immune system, specifically a type of immune cell called CD8+ T cells. These cells are important for fighting cancer. Researchers want to see if Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT) can increase these CD8+ T cells in tumors. You would receive an imaging procedure called a PET scan using Zirconium Zr 89-Df-Crefmirlimab to measure these cells before and after radiation. This study is for people with metastatic solid tumors or lymphoma, aged 18 or older, and aims to enroll 10 participants. The main goal is to see if there's a change in CD8+ T cells after radiation therapy.

Study design
This is an interventional study with no specified phase, planning to enroll 10 participants. It is not stated if it is randomized or blinded.
What's involved
You would undergo PET scans and receive either SBRT or IMRT. Blood samples will also be collected.
Compensation
Not stated in the trial record.
Follow-up
CD8 PET SUV will be measured at day -1 (pre-SBRT) and at 1 week after completion of SBRT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05371132

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

Recruiting
PHASE1Ages 18+InterventionalBasic science
City of Hope Medical Center
~10 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Positron Emission TomographyStereotactic Body Radiation TherapyZirconium Zr 89-Df-CrefmirlimabIntensity Modulated Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
Measured over Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)

Conditions

Metastatic Malignant Solid Neoplasm
Lymphoma

Explore related trials

LymphomaSolid Neoplasm

NCT05371132

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Savita V Dandapani · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Savita V. Dandapani
[email protected]
626-359-8111
Email the study team

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Participant is willing and able to comply with all protocol required procedures
Age: \>= 18 years
Eastern Cooperative Oncology Group (ECOG) =\< 2
Metastatic patients of any solid tumor malignancy amenable for SBRT as determined by the radiation oncologist
Lymphoma patients may be allowed as determined by the principal investigator (PI)
No change in systemic treatment regimen for past 2 months prior to start of SBRT
Patients able to comply with daily PET after SBRT
Patient meets all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use effective double barrier contraceptive methods or abstain from heterosexual activity for the course of the study through at least 30 days after the last administration of the CD8 PET tracer
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

Patient who have splenic disorders or had splenectomy that per PI would interfere with CD8 imaging
Patients should not have any uncontrolled illness including ongoing or active infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CD8 PET tracer
Serious nonmalignant disease or conditions that could compromise protocol objectives, in the opinion of the investigator
Females only: Pregnant or breastfeeding
Pregnant women are excluded from this study because CD8 PET tracer is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CD8 PET tracer, breastfeeding should be discontinued if the mother is treated with CD8 PET tracer
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

What this trial measures

  • Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)

    CD8 PET SUV will be measured as SUVmax, the maximum SUV measurement within the tumor voxels. If patients have multiple tumors treated with stereotactic body radiation therapy (SBRT), average within-tumor change will be used for that patient for the primary analysis. As a result, this primary analysis is a comparison of the change in CD8 PET SUV in 10 patients.