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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

StatusCompleted
PhaseEarly Phase 1
Started2025-10-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
notable
Trial completed
Study completion confirmed: April 2026 (last estimated December 2026)
2026-06-24
critical
Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations v3
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 40 → 4 participants
Sponsor changed: Kirsten Johnson → Ohio State University Comprehensive Cancer Center+34 characters
WasKirsten Johnson
NowOhio State University Comprehensive Cancer Center
Primary completion moved earlier: 2026-12-31 → 2026-04-03
Study sitesdetails revised at 1 of 1 site
2026-02-10
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v2
Lead sponsorBrittany Dulmage→Kirsten Johnson
Study sitescontacts updated at 1 of 1 site
2025-10-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-01→confirmed 2025-10-16
Study sitesdetails revised at 1 of 1 site
2025-08-23
minor
Original filing
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.
Trial Details
NCT Number NCT07144384
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Skin Basal Cell Carcinoma, Skin Nodular Basal Cell Carcinoma, Skin Squamous Cell Carcinoma
Enrollment 4 participants
Start Date 2025-10-16
Primary Completion 2026-04-03 (estimated)
Study Completion 2026-04-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-28