This phase I trial investigates the effect of radiation therapy on the immune system, specifically CD8 positive (+) T cells. 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05371132.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer CenterStatus: Active
Contact: Savita Visalakshi Dandapani
Phone: 626-359-8111
PRIMARY OBJECTIVE:
I. Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT)/intensity-modulated radiation therapy (IMRT) 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/IMRT.
V. To assess ability of CD8 PET tracer and imaging to be a biomarker of SBRT/IMRT.
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/IMRT.
VIII. Conduct subset analysis for the three likely radiation therapy (RT) schedules (lymphoma, myeloma and other solid tumors).
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 chimeric antigen receptor t cell (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/IMRT. Patients undergo SBRT/IMRT every 2-5 days for a total of 5 fractions. Additionally, patients with lymphoma may optionally receive zirconium Zr 89-Df-crefmirlimab IV over 5-10 minutes and then undergo PET imaging 24 hours after infusion after completion of standard of care CAR-T cell therapy. Patients undergo computed tomography (CT), magnetic resonance imaging and/or PET/CT during screening. Patients also undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 4-6 weeks, 3 months, 1 year, and then periodically for 2 years.
Trial PhasePhase I
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorSavita Visalakshi Dandapani