RecruitingEarly Phase 1

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

United States40 participantsStarted 2025-10-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 f…

What they're measuring

Change in intratumoral natural killer (NK) cell content

Timeframe: Up to 2 weeks after locoregional injection of NK cells

Trial details

NCT IDNCT07144384

SponsorKirsten Johnson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu