Injecting donor natural killer cells, including TGF-beta‑imprinted NKs, into skin squamous and basal cell cancers
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
EARLY_PHASE1 · Ohio State University Comprehensive Cancer Center · NCT07144384
This trial will try injecting two types of donor natural killer (NK) immune cells into adults' skin squamous cell and basal cell cancers to see which type stays in the tumor longer and whether the injections are safe before surgical removal.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Drugs / interventions | cepilimumab, pembrolizumab, nivolumab, ipilimumab, radiation, methotrexate |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07144384 on ClinicalTrials.gov |
What this trial studies
This early-phase randomized trial enrolls adults with biopsy-proven cutaneous squamous cell carcinoma (SCC) or nodular/aggressive basal cell carcinoma (BCC) who are scheduled for standard surgical excision. Participants are randomized to receive a single intratumoral injection of either universal donor (UD) expanded NK cells or UD TGF‑beta‑imprinted NK cells (from CMV-exposed donors) between days 10–28 after biopsy and then undergo surgical excision 4–8 weeks after biopsy. The primary aim is to measure persistence of NK-cell infiltration in the tumor, with secondary endpoints that include tolerability (CTCAE v5) and feasibility for a larger study. Exploratory analyses compare tumor size/appearance changes and the presence of NK and other immune cells in the tumor microenvironment between cell types and tumor histologies.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) at Ohio State with a biopsy-confirmed cutaneous SCC or nodular/aggressive BCC measuring at least 1 cm that is accessible for intratumoral injection and planned for standard surgical excision.
Not a fit: Patients who have recent or planned radiation or systemic cancer treatments, tumors smaller than 1 cm or not accessible to injection, or who are not surgical candidates are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could boost local immune attack on skin tumors and potentially reduce residual disease or improve outcomes from surgical removal.
How similar studies have performed: While NK-cell therapies have shown promise in preclinical studies and some early-phase trials, using CMV-adaptive, TGF‑beta‑imprinted donor NK cells injected directly into skin tumors is a novel approach with limited clinical outcome data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 of baseline * Willingness to follow up for residual cancer extirpation between 2-8 weeks after the injection Exclusion Criteria: * 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Kirsten Johnson, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin Basal Cell Carcinoma, Skin Nodular Basal Cell Carcinoma, Skin Squamous Cell Carcinoma