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.
Additional locations may be listed on ClinicalTrials.gov for NCT07144384.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Brittany L Dulmage
Phone: 614-293-1707
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.
EXPLORATORY/CORRELATIVE OBJECTIVES:
I. 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.
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorBrittany L Dulmage
