Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
City of Hope Medical Center
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."
Description
PRIMARY OBJECTIVE: I. Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT) in irradiated tumors. SECONDARY OBJECTIVES: I. To report on the time evolution of zirconium Zr 89-Df-crefmirlimab (CD8 PET tracer) uptake after infusion. II. To compare CD8 PET tracer uptake at irradiated lesions to uptake at non-irradiated lesions (if any). III. To assess how differences in site, histology and/or prior therapy relate to immune characterization and changes IV. To assess serum biomarkers of immune response before and after SBRT. V. To assess ability of CD…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Pati…
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
Location
- City of Hope Medical CenterDuarte, California