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
Kirsten Johnson
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.
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) TGFbeta-resistant NK cells in a cohort of patients prior to their standard of care excision. SECONDARY OBJECTIVES: I. 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. EX…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 o…
Interventions
- ProcedureBiopsy Procedure
Undergo SOC biopsy
- BiologicalNatural Killer Cell Therapy
Given UD expanded NK cells intratumorally
- ProcedureSurgical Procedure
Undergo SOC excision
- BiologicalUniversal Donor Expanded TGF-beta-imprinted NK Cells
Given intratumorally
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio