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RECRUITING
NCT07144384
EARLY_PHASE1

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

View on ClinicalTrials.gov

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

PROCEDURE

Biopsy Procedure

Undergo SOC biopsy

BIOLOGICAL

Natural Killer Cell Therapy

Given UD expanded NK cells intratumorally

PROCEDURE

Surgical Procedure

Undergo SOC excision

BIOLOGICAL

Universal Donor Expanded TGF-beta-imprinted NK Cells

Given intratumorally

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States