Recruiting
Phase 1

CD8 PET Imaging

Sponsor:

City of Hope Medical Center

Code:

NCT05371132

Conditions

Metastatic Malignant Solid Neoplasm

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positron Emission Tomography

Stereotactic Body Radiation Therapy

Zirconium Zr 89-Df-Crefmirlimab

Intensity Modulated Radiation Therapy

Study Details

Brief 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."

Conditions

Metastatic Malignant Solid Neoplasm

Lymphoma

Study ID

NCT05371132

Start date

Jun 20, 2022

Status verified date

Jan, 2026

Completion date

Oct 5, 2026

Anticipated

Primary completion date

Oct 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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 Criteria:

  • 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)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Positron Emission Tomography

Undergo PET

Stereotactic Body Radiation Therapy

Undergo SBRT

Zirconium Zr 89-Df-Crefmirlimab

Given IV

Intensity Modulated Radiation Therapy

IMRT for Lymphoma patients only

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) ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Savita V. Dandapani

626-359-8111sdandapani@coh.org

Principal Investigator:

Savita V. Dandapani

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-01-28.