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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05371132
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lymphoma
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT
  • Zirconium Zr 89-Df-Crefmirlimab — DRUG
    Given IV
  • Intensity Modulated Radiation Therapy — RADIATION
    IMRT for Lymphoma patients only

Study Details

"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."

Key Dates

Start date
Jun 20, 2022
Status verified
Jan 2026
Primary completion
Oct 5, 2026
Completion
Oct 5, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)
    Patients receive zirconium Zr 89-Df-crefmirlimab IV over 5-10 minutes and then under PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions. For lymphoma patients only, IMRT on consecutive days may be used.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Savita V. Dandapani
[email protected]
626-359-8111
Savita V. Dandapani (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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