Actively Recruiting
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
Led by Kirsten Johnson · Updated on 2026-02-13
40
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years at Ohio State University
- Diagnosis of at least 1 cm keratinocyte carcinoma accessible to intratumoral injection
- Confirmed diagnosis of cutaneous squamous cell carcinoma or basal cell carcinoma by biopsy
- Basal cell carcinoma of nodular or aggressive subtype
- Squamous cell carcinoma well-differentiated or aggressive subtype with T1 or T2 staging
- Eligible for standard care surgical treatment with wide local excision or Moh's surgery
- Presence of residual tumor of at least 1 cm at baseline
- Willing to follow up for tumor removal surgery between 2 and 8 weeks after injection
You will not qualify if you...
- Planned or current radiation or systemic cancer treatment including chemotherapy or immunotherapy within 6 weeks prior to enrollment
- Age under 18 years
- Negative deep and peripheral biopsy margins
- Basal cell carcinoma superficial subtype
- Squamous cell carcinoma in situ, basosquamous, keratoacanthoma-type, or greater than T2 staging
- Presence of skin disease or active infection at the tumor site
- Unable to follow up for surgical tumor removal
- Any condition making participation unsafe, including active infection, pregnancy, breastfeeding
- Use of other investigational drugs within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here