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NCT07144384 · ClinicalTrials.gov registry record · Early 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
A Early Phase 1 study of Skin Squamous Cell Carcinoma and Skin Basal Cell Carcinoma, sponsored by Kirsten Johnson.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07144384: Recruiting Early Phase 1 study of Skin Squamous Cell Carcinoma and Skin Basal Cell Carcinoma, sponsored by Kirsten Johnson.
NCT07144384 is a Early Phase 1 study of Skin Squamous Cell Carcinoma and Skin Basal Cell Carcinoma that is actively recruiting participants, run by Kirsten Johnson. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07144384, a Early Phase 1 study of Skin Squamous Cell Carcinoma and Skin Basal Cell Carcinoma, is actively recruiting participants, sponsored by Kirsten Johnson.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biopsy Procedure
- PROCEDURE Surgical Procedure
- BIOLOGICAL Natural Killer Cell Therapy
- BIOLOGICAL Universal Donor Expanded TGF-beta-imprinted NK Cells
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-10-16 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT07144384 shows while recruiting
NCT07144384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 3 conditions, with Skin Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biopsy Procedure is the first listed.
NCT07144384 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07144384 about?
NCT07144384 is a clinical study titled "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". 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 (intratum...
What is the current status of trial NCT07144384?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2025-10-16. Estimated completion is 2026-12-31.
What conditions does trial NCT07144384 study?
This clinical trial studies the following conditions: Skin Squamous Cell Carcinoma, Skin Basal Cell Carcinoma, Skin Nodular Basal Cell Carcinoma.
What interventions are being tested in trial NCT07144384?
The interventions under investigation include: Biopsy Procedure (PROCEDURE), Surgical Procedure (PROCEDURE), Natural Killer Cell Therapy (BIOLOGICAL), Universal Donor Expanded TGF-beta-imprinted NK Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07144384?
This trial is sponsored by Kirsten Johnson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07144384 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07144384's enrollment target sits among peer trials
40 629th of 2000 higher than 1,313 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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