Natural Killer Cell Therapy for Skin Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brittany Dulmage

Must not be taking: Chemotherapies, Immunotherapies

Disqualifiers: Radiation, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two special types of white blood cells, known as natural killer (NK) cells, to determine their safety and effectiveness in treating skin cancers like squamous cell carcinoma (SCC) and basal cell carcinoma (BCC). Researchers aim to discover if these NK cells can more effectively kill cancer cells when injected directly into the tumor. One group will receive standard NK cells, while the other will receive NK cells potentially enhanced by exposure to a common virus. This trial may suit individuals with a skin cancer tumor at least 1 cm in size that can be injected with these cells. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial requires that you do not have any planned or recent (within 6 weeks) treatments like chemotherapy or immunotherapy for cancer. If you're on such treatments, you would need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NK cells, a type of white blood cell, can be safely used in cancer treatments. These cells fight cancer by finding and destroying tumor cells. Some studies have safely used NK cells from healthy donors, even when the donor and recipient are not a perfect match.

For TGF-beta-imprinted NK cells, early results suggest they might be safe and possibly more effective than regular NK cells at targeting tumor cells. These specially modified NK cells come from donors exposed to a common virus, which might enhance their ability to kill cancer cells.

Since this trial is in an early stage, it primarily focuses on safety. Early-stage studies usually involve small groups to closely monitor side effects and assess how well participants tolerate the treatment. Safety information is still being collected, and further research is needed to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they use natural killer (NK) cells, a type of immune cell that can target and destroy cancer cells. Unlike traditional treatments for skin cancer, such as surgery, chemotherapy, or radiation, these NK cells are expanded and imprinted with TGF-beta to enhance their ability to fight cancer more effectively. The treatments are administered directly into the tumor, which may lead to faster and more targeted action against cancer cells. This innovative approach holds promise for improving outcomes and reducing side effects compared to conventional options.

What evidence suggests that this trial's treatments could be effective for skin cancer?

Research has shown that natural killer (NK) cells can help fight cancer. In past studies, NK cells from universal donors have been safe and effective in slowing tumor growth, particularly in skin cancer like melanoma. NK cells, a type of white blood cell, can find and destroy cancer cells by detecting unusual or missing proteins.

In this trial, participants will receive one of two types of NK cell treatments. Cohort I will receive Universal Donor Expanded NK cells, while Cohort II will receive TGF-beta-imprinted NK cells. Early research suggests that TGF-beta-imprinted NK cells might be even more effective. These cells come from donors exposed to a common virus called CMV, which may enhance their ability to kill cancer cells. They also release substances that strengthen the body's immune response. Overall, these NK cells show promise as a treatment for skin cancers, including squamous cell carcinoma and basal cell carcinoma. ^{1 2 3 6 7}

Who Is on the Research Team?

Brittany L Dulmage, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with skin squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). Participants should have a tumor that can be injected and must not have received certain treatments prior to the study. They need to meet specific health criteria, which will be assessed by the research team.

Inclusion Criteria

I am over 18 and a patient at Ohio State University.

My skin cancer (SCC or BCC) was confirmed by a biopsy.

I am eligible for surgery to remove my skin cancer.

Exclusion Criteria

Receipt of any other investigational drugs within the 30 days prior to screening visit

My skin cancer is a specific type or more advanced than early stage.

Negative deep and peripheral margin status from the diagnostic biopsy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive intratumoral injections of either UD expanded NK cells or UD expanded TGF-beta-i NK cells

4-8 weeks

Multiple visits for biopsy, injection, and excision

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Universal Donor Expanded TGF-beta-imprinted NK Cells

Trial Overview The trial compares two types of natural killer (NK) cell therapies: standard universal donor NK cells and TGF-beta imprinted NK cells, both administered directly into the tumor. It aims to evaluate their safety, side effects, and effectiveness in treating SCC or BCC.

How Is the Trial Designed?

Group I: Cohort II (UD expanded TGFbetai NK cells) Experimental Treatment 3 Interventions

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.

Group II: Cohort I (UD expanded NK cells) Experimental Treatment 3 Interventions

Patients undergo 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.

Who Is Running the Clinical Trial?

Brittany Dulmage

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07144384

Intratumoral Injection of Standard Universal Donor ... 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. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346276/

Supercharged Natural Killer (sNK) Cells Inhibit Melanoma ... Results: Our investigation showed promising outcomes, as sNK cell infusions effectively inhibited melanoma tumor growth in hu-BLT mice. These ...

3. pediatricsnationwide.org pediatricsnationwide.org/2025/09/15/universal-donor-car-nk-cells-a-new-platform-technology-for-cancer/

Universal Donor CAR NK Cells: A New Platform ... “In our studies, we've seen very positive results using universal donor CAR NK cells,” says Dr. Pereira. “When mice are treated with CAR T ...

4. cell.com cell.com/cancer-cell/abstract/S1535-6108(25)00405-2

Engineered natural killer cells for cancer therapy Early-phase clinical trials have demonstrated remarkable safety and encouraging therapeutic efficacy of chimeric antigen receptor (CAR)-NK cells ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8471577/

Adoptive NK Cell Therapy: A Promising Treatment ... Taken together, these data show that NK cells play an important role in melanoma immune surveillance, but NK cell function is often impaired both in the TME as ...

6. nature.com nature.com/articles/s41423-024-01145-x

Development of NK cell-based cancer immunotherapies ... Thus, NK cells from healthy donors can be safely used for cancer therapy, even in the case of HLA mismatch between the donor and recipient, thus ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2736058/

Clinical Grade Ex Vivo-Expanded Human Natural Killer ... A pure population of clinical grade NK cells expanded 490±260 fold over 21 days. Expanded NK cells had increased TRAIL, FasL, and NKG2D expression and ...