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Skin Basal Cell CarcinomaEarly Phase 1NCT07144384

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 testing Biopsy Procedure, Natural Killer Cell Therapy and Surgical Procedure in people with Skin Basal Cell Carcinoma and Skin Nodular Basal Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Natural Killer Cell Therapy and Surgical Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
16 Oct 2025to 7 Apr 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Pilot Study Testing Intralesional Injection of Ex-Vivo Expanded Allogenic University Donor (UD) NK and TGFBi NK Cells in Patients With Cutaneous Keratinocyte Carcinomas

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the persistence of NK cell infiltration within biopsy-proven keratinocyte carcinomas following intra-tumoral injection of universal donor NK cells versus (vs) TGFbeta-resistant NK cells in a cohort of patients prior to their standard of care excision.

SECONDARY OBJECTIVES:

  1. To assess the tolerability of NK cell cutaneous intra-tumoral injection measured by adverse events, described using Common Terminology for Cancer Related Adverse Events (CTCAE version [v] 5).

II. To test the feasibility of a larger study using intra-tumorally injected NK cells.

EXPLORATORY/CORRELATIVE OBJECTIVES:

  1. To assess clinical outcomes including size, area change, and visual appearance in clinical detection of keratinocyte carcinomas between injection and excision.

II. To compare NK and other immune cell presence within the tumor/tumor microenvironment (TME) in cutaneous basal cell carcinomas (BCCs) vs squamous cell carcinomas (SCCs) injected with NK vs TGFbetai cells prior to excision.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT I: Patients undergo standard of care (SOC) biopsy on day 0 and within 4 weeks (days 10-28) receive UD expanded NK cells intratumorally. Patients undergo SOC excision 4-8 weeks (days 28-56) after biopsy.

COHORT II: Patients undergo SOC biopsy on day 0 and within 4 weeks (days 10-28) receive UD expanded TGF-beta-i NK cells intratumorally. Patients undergo SOC excision 4-8 weeks (days 28-56) after biopsy.

Being tested
Biopsy Procedure, Natural Killer Cell Therapy, Surgical Procedure, Universal Donor Expanded TGF-beta-imprinted NK Cells
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo SOC biopsy

  • Natural Killer Cell TherapyBiological

    Given UD expanded NK cells intratumorally

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo SOC excision

  • Universal Donor Expanded TGF-beta-imprinted NK CellsBiological

    Also called Allogeneic TGFBi Expanded NK Cells, UD TGF-betai NK Cells, Universal Donor TGF-beta Imprinted Expanded NK Cells

    Given intratumorally

Study groups in NCT07144384
Study groupRoleWhat they receive
Cohort I (UD expanded NK cells)ExperimentalPatients undergo SOC biopsy on day 0 and within 4 weeks (days 10-28) receive UD expanded NK cells intratumorally. Patients undergo SOC excision 4-8 weeks (days 28-56) after biopsy.
Receives: Procedure: Biopsy Procedure; Biological: Natural Killer Cell Therapy; Procedure: Surgical Procedure
Cohort II (UD expanded TGFbetai NK cells)ExperimentalPatients undergo SOC biopsy on day 0 and within 4 weeks (days 10-28) receive UD expanded TGF-beta-i NK cells intratumorally. Patients undergo SOC excision 4-8 weeks (days 28-56) after biopsy.
Receives: Procedure: Biopsy Procedure; Procedure: Surgical Procedure; Biological: Universal Donor Expanded TGF-beta-imprinted NK Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intratumoral natural killer (NK) cell content

    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.

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

Secondary outcomes (1)

  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 criteria

    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be summarized as the percentage of patients experiencing each type and grade of event according to dose level. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

    Measured: Up to 8 weeks after biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start16 Oct 2025
  3. Primary completion3 Apr 2026
  4. Study completion7 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144384
Sponsor's protocol ID
OSU-24311
Other IDs
NCI-2025-05655
Status last verified
Jun 2026
First submitted
12 Aug 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biopsy Procedure, Natural Killer Cell Therapy and Surgical Procedure in people with Skin Basal Cell Carcinoma and Skin Nodular Basal Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intratumoral natural killer (NK) cell content (time frame: Up to 2 weeks after locoregional injection of NK cells). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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