RecruitingEarly Phase 1NCT07144384

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

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

Sponsor

Kirsten Johnson

Enrollment

40 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

Skin Squamous Cell Carcinoma Skin Basal Cell Carcinoma Skin Nodular Basal Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting natural killer (NK) immune cells directly into skin cancers — specifically squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) — can help shrink the tumors before surgery. Two types of NK cells (standard and TGF-beta imprinted) will be tested. **You may be eligible if...** - You are a patient at Ohio State University who is 18 years or older - You have a confirmed skin cancer (SCC or BCC) that is at least 1 cm in size and can be reached by injection - Your cancer is a specific subtype (nodular or aggressive BCC; well-differentiated or aggressive SCC at T1 or T2 stage) - You are already scheduled for standard surgical removal of the cancer - You still have visible cancer at the start of the study **You may NOT be eligible if...** - You are currently receiving or plan to receive radiation or systemic therapy (chemotherapy, immunotherapy) for any cancer - Your diagnostic biopsy completely removed the cancer with clear margins - Your cancer is a superficial BCC, or SCC in situ, or other excluded subtypes - You are unable to follow up for surgery after the injection - You are pregnant, breastfeeding, or likely to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo SOC biopsy

BIOLOGICALNatural Killer Cell Therapy

Given UD expanded NK cells intratumorally

PROCEDURESurgical Procedure

Undergo SOC excision

BIOLOGICALUniversal Donor Expanded TGF-beta-imprinted NK Cells

Given intratumorally

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07144384

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