Clinical Trial · NCT05371132

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

Overview

"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."

Sponsor

City of Hope Medical Center

Phase

Phase 1

Contacts

Savita V Dandapani (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05371132

Drug / Compound

Df-Crefmirlimab

Isotope(s):

Target(s):

CD8 Cells

Ligand Class: Small Proteins and Antibody Fragments

Chelator: DFO

Eligibility

Inclusion

Eastern Cooperative Oncology Group (ECOG) =\< 2
Metastatic patients of any solid tumor malignancy amenable for SBRT as determined by the radiation oncologist
Age: \>= 18 years
* Documented informed consent of the participant and/or legally authorized representative
Participant is willing and able to comply with all protocol required procedures

Exclusion

* Patient who have splenic disorders or had splenectomy that per PI would interfere with CD8 imaging
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
Patients should not have any uncontrolled illness including ongoing or active infection