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Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer Cells for the Treatment of Skin Squamous Cell Carcinoma and Basal Cell Carcinoma
Sponsor: Kirsten Johnson
Summary
This early phase I trial compares the safety, side effects and the biological or cellular activity of two types of universal donor (UD) natural killer (NK) cells (standard NK cells and transforming growth factor \[TGF\] beta imprinted \[TGF-beta-i\] NK cells), given directly into the tumor (intratumoral) in treating patients with skin (cutaneous) squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). NK cells are a type of white blood cell that can recognize missing or incorrect proteins on tumor cells and then kill these tumor cells. It was recently discovered that infection with human cytomegalovirus (CMV), a common virus, leads to the development of a unique NK cell population. These "adaptive" NK cells have a more potent anti-tumor killing action. The TGF-beta-i NK cells used in this study are created using donors whose blood tests positive for CMV exposure. This may make them more effective at killing tumor cells. Giving UD TGF-beta-i NK cells may be safe, tolerable and/or more effective than standard UD expanded NK cells in treating patients with SCC or BCC.
Official title: A Pilot Study Testing Intralesional Injection of Ex-Vivo Expanded Allogenic University Donor (UD) NK and TGFBi NK Cells in Patients With Cutaneous Keratinocyte Carcinomas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-10-16
Completion Date
2026-12-31
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
Biopsy Procedure
Undergo SOC biopsy
Natural Killer Cell Therapy
Given UD expanded NK cells intratumorally
Surgical Procedure
Undergo SOC excision
Universal Donor Expanded TGF-beta-imprinted NK Cells
Given intratumorally
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States