Immune cells injected into skin tumors show promise in early trial
NCT ID NCT07144384
First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This early-phase trial tests whether injecting special immune cells (natural killer cells) directly into skin cancer tumors can safely kill cancer cells. The study compares two types of donor NK cells—standard ones and ones engineered to be more potent—in 40 patients with basal or squamous cell carcinoma. The main goal is to see if the cells enter the tumor and cause any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Natural killer (NK) cells (standard and TGF-beta-imprinted) injected directly into the tumor
- What this could lead to
- If it works, this could point toward a new way to treat common skin cancers without surgery, using the body's own immune cells.
- What could go wrong
- This is a very early (Phase 1) pilot study with only 40 people. It is designed mainly to check safety and immune activity, not to prove the treatment works. The cells may not shrink tumors or could cause side effects like inflammation or injection reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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4 people
The number who actually took part.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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