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

Recruiting now · Phase 1

Conditions studied: Metastatic Malignant Solid Neoplasm, Lymphoma

In brief

"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 facts

Study ID: NCT05371132
Run by: City of Hope Medical Center
People needed: 10
Starts: 2022-06-20
Expected to finish: 2026-10-05
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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)

Where it is running

City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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