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

NCT07144384 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: OSU-24311NCI-2025-05655
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Up to 2 weeks after locoregional injection of NK cells

Secondary Outcomes (1)

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

  Up to 8 weeks after biopsy

Study Arms (2)

Cohort I (UD expanded NK cells)

EXPERIMENTAL

Patients 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.

Procedure: Biopsy Procedure; Biological: Natural Killer Cell Therapy; Procedure: Surgical Procedure

Cohort II (UD expanded TGFbetai NK cells)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Surgical Procedure; Biological: Universal Donor Expanded TGF-beta-imprinted NK Cells

Interventions

Biopsy Procedure PROCEDURE

Undergo SOC biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Cohort I (UD expanded NK cells); Cohort II (UD expanded TGFbetai NK cells)

Natural Killer Cell Therapy BIOLOGICAL

Given UD expanded NK cells intratumorally

Cohort I (UD expanded NK cells)

Surgical Procedure PROCEDURE

Undergo SOC excision

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Cohort I (UD expanded NK cells); Cohort II (UD expanded TGFbetai NK cells)

Universal Donor Expanded TGF-beta-imprinted NK Cells BIOLOGICAL

Given intratumorally

Also known as: Allogeneic TGFBi Expanded NK Cells, UD TGF-betai NK Cells, Universal Donor TGF-beta Imprinted Expanded NK Cells

Cohort II (UD expanded TGFbetai NK cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsten Johnson: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Biopsy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Investigative Techniques

Study Officials

• Kirsten Johnson, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 27, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)