A Phase 1 interventional study of Positron Emission Tomography and Stereotactic Body Radiation Therapy in Metastatic Malignant Solid Neoplasm and Lymphoma, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Basic science
"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."
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 CD8 PET tracer and imaging to be a biomarker of SBRT. VI. Evaluate CD8 PET tracer with Response Evaluation Criteria in Solid Tumors (RECIST) radiology measurements.
VII. To report any adverse events associated with 2 doses of CD8 PET tracer when used in combination with SBRT.
EXPLORATORY OBJECTIVE:
I. Blood will be collected, processed, and stored for future immune profiling or other correlatives pending additional funding.
II. Evaluate the safety and feasibility of using CD8 PET imaging to assess immune system activation during and after bRT for CAR T cell therapy.
III. Describe the CD8 PET tracer uptake prior to CAR T and the response/duration of response to CAR T cell therapy
OUTLINE:
Patients receive zirconium Zr 89-Df-crefmirlimab intravenously (IV) over 5-10 minutes and then undergo PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions.
The subset of lymphoma patients enrolled on trial who are being treated in the bridging radiation setting before CAR T-cell therapy will receive 3 infusions of Zr89-Df-crefmirlimab and associated CD8 ImmunoPET imaging before radiation, after radiation, and after CAR T-cell infusion.
After completion of study treatment, patients are followed up at 4-6 weeks, 3 months, 1 year, and then periodically for 2 years.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 10 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
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
Exclusion Criteria:
Females only: Pregnant or breastfeeding
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.
Procedure: Positron Emission Tomography · Radiation: Stereotactic Body Radiation Therapy · Drug: Zirconium Zr 89-Df-Crefmirlimab · Radiation: Intensity Modulated Radiation Therapy
Undergo PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Given IV
Also known as: 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2C, Zirconium Zr 89-Df-IAB22M2C, ZIRCONIUM ZR-89-DESFERRIOXAMINE-IAB22M2C
IMRT for Lymphoma patients only
Also known as: IMRT
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
CD8 PET SUV will be measured as SUVmax, the maximum SUV measurement within the tumor voxels. If patients have multiple tumors treated with stereotactic body radiation therapy (SBRT), average within-tumor change will be used for that patient for the primary analysis. As a result, this primary analysis is a comparison of the change in CD8 PET SUV in 10 patients.
Time frame: Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)
Time evolution of CD8 PET SUV (decay corrected)
CD8 PET SUVs from PET scans taken before, during and after SBRT.
Time frame: From pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT)
Site specific differences in immune characterization (CD8 PET SUV) and changes
CD8 PET SUV and change in CD8 PET SUV at tumor sites will be collected to assess whether immune activity and response is different at different sites of disease (e.g., lymph node vs bone)
Time frame: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Histology specific differences in immune characterization (CD8 PET SUV) and changes
CD8 PET SUV and change in CD8 PET SUV will be collected to assess whether immune activity and response is different depending on the patient's disease type and histopathology.
Time frame: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Evaluation of tumor response (fludeoxyglucose F-18 [FDG] PET and/or computed tomography [CT]) as it relates to both baseline CD8 PET SUV and changes observed after SBRT.
RECIST response and evaluation endpoints will be used to assess tumor response from CT imaging, and SUVmax will be used for FDG-PET imaging. Data will be compared with CD8 PET SUVs (e.g. SUVmax of CD8 PET) and changes pre- and post-SBRT. For multiple lesions irradiated SUVmax will be averaged.
Time frame: Pre-SBRT to post-SBRT (1-2 weeks after completion of SBRT). Additional RECIST response assessments will be conducted per standard of care and will be assessed for up to 2 years to compare to CD8 SUVs post-SBRT and changes in CD8 SUVs.
CD8 PET SUV (Subset)
Will describe CD8 PET SUV in the subset (approximately 2 patients) who receive CAR-T therapy, and those patients' response/duration of response to CAR-T. CD8 PET SUVs from PET scans taken before, during and after bridging radiation, as well as after CAR T cell therapy. Response to radiation and CAR T and survival after the combination treatment will be collected and compared to CD8 uptake patterns.
Time frame: Pre-bridging radiation to post-CAR T cell therapy (approximately at least 7 days after CAR T cell infusion). Additional response and survival data will be collected up to 2 years after completion of study therapy.
Incidence of adverse events
Number and type of adverse events related to the study treatment
Time frame: From the first CD8 PET tracer infusion to 4-6 weeks after the last CD8 PET tracer infusion.
Correlation between immune characterization of blood samples and CD8 PET SUVs and tumor response
Changes in circulating levels of immune cells and cytokines will be compared to changes in CD8 PET SUVs and tumor response (measured by RECIST or FDG PET SUVs). If multiple lesions, the average will be used. Most metrics will use SUVmax, although others will be explored.
Time frame: Pre-SBRT to post-SBRT (1 week after completion of SBRT)
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