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Early Phase Study of NK Cell Therapy for Skin Cancers

This early-phase study is testing two types of natural killer (NK) cells, which are white blood cells that can fight cancer, for people with skin squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). Researchers are giving either "Universal Donor Expanded Natural Killer Cells" or "Universal Donor Expanded TGF-beta-imprinted NK Cells" directly into the tumor. The main goal is to see how many NK cells remain in the tumor after injection. To join, you must be an Ohio State University patient over 18 with a keratinocyte carcinoma (skin cancer) at least 1cm in size that can be injected. This study aims to understand the safety and biological effects of these treatments before a larger study.

Study design
This is an early-phase interventional study with a planned enrollment of 4 participants. Participants will be randomized to receive one of the two NK cell therapies.
What's involved
You will undergo a standard biopsy, receive an intratumoral injection of NK cells, and then have a standard surgical removal of the tumor. These procedures will occur over several weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in NK cell content up to 2 weeks after the injection. The study also assesses outcomes between injection and excision, which can be up to 8 weeks after biopsy.

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NCT07144384

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

Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~4 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Biopsy ProcedureNatural Killer Cell TherapySurgical ProcedureUniversal Donor Expanded TGF-beta-imprinted NK Cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in intratumoral natural killer (NK) cell content
Measured over Up to 2 weeks after locoregional injection of NK cells

Conditions

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

Explore related trials

Basal Cell CarcinomaSquamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Kirsten Johnson, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ohio State University patients \> 18 years old
Diagnosis of ≥ 1cm keratinocyte carcinoma, accessible by intra-tumoral injection
Confirmation of cutaneous SCC (cSCC) (10 patients total) or BCC (10 patients total) via diagnostic biopsy
BCC: Nodular or aggressive subtype
SCC: Well-differentiated or aggressive subtype with T1 or T2 staging by American Joint Committee on Cancer (AJCC) criteria
Patient meets criteria for standard of care surgical treatment with either wide local excision or Moh's surgery
Presence of residual clinical cancer ≥ 1cm at the time of baseline
Willingness to follow up for residual cancer extirpation between 2-8 weeks after the injection

Exclusion

Planned or concurrent radiation or systemic treatment for solid tumor or hematologic malignancy including chemotherapies or immunotherapies received within 6 weeks of trial enrollment. These include but are not limited to methotrexate, 5-fluorouracil, vismodegib, cepilimumab, pembrolizumab, nivolumab, ipilimumab for any skin malignancy
\< 18 years old
A negative deep and peripheral margin status from the diagnostic biopsy
Diagnostic biopsy with the following histopathologic characteristics:
BCC: Superficial subtype
SCC: SCC in situ (SCCIS)/Bowen disease, basosquamous, keratoacanthoma (KA)-type SCC, or tumor with \> T2 staging by AJCC criteria
Any skin disease or active infection in the same area that may confound assessments
Inability to follow-up for definitive treatment (surgical excision)
Any other comorbidity or complication that in the opinion of the investigator could make the patient unsafe to participate in the study, such as:
Active infection
Pregnant women, women who are likely to become pregnant or are breastfeeding
Patients who received any other investigational drugs within the 30 days prior to screening visit

What this trial measures

  • Change in intratumoral natural killer (NK) cell contentUp to 2 weeks after locoregional injection of NK cells

    Immunohistochemical and in vitro studies of tissue from the original biopsy and post-NK cell treated tumor specimens will be performed to assess NK cell infiltration of the tumor. Difference in NK cell density by CD56 staining in pre- versus post-intervention skin tumor tissue will be compared between tumors receiving NK versus transforming growth factor betai cell injections.