Status:
RECRUITING
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
Lead Sponsor:
Brittany Dulmage
Conditions:
Skin Basal Cell Carcinoma
Skin Nodular Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 gr...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the persistence of NK cell infiltration within biopsy-proven keratinocyte carcinomas following intra-tumoral injection of universal donor NK cells versus (vs) TGFbe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07144384
Start Date
October 16 2025
End Date
December 31 2026
Last Update
October 24 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210