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Natural Killer Cell Therapy

Phase 1

Skin Basal Cell Carcinoma | Monoclonal antibody | Oncology |Johnson & Johnson|Last Updated: Feb 13, 2026

Success Probability

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Natural Killer Cell Therapy · 1 trial · 3 indications

Early Phase 1 1
NCT07144384Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer Cells for the Treatment of Skin Squamous Cell Carcinoma and Basal Cell CarcinomaSkin Basal Cell Carcinoma
RECRUITING40 Analytics
EARLY_PHASE1RECRUITING
Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer Cells for the Treatment of Skin Squamous Cell Carcinoma and Basal Cell Carcinoma
Skin Basal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in intratumoral natural killer (NK) cell content
Up to 2 weeks after locoregional injection of NK cells

Immunohistochemical and in vitro studies of tissue from the original biopsy and post-NK cell treated tumor specimens will be performed to assess NK cell infiltration of the tumor. Difference in NK cell density by CD56 staining in pre- versus post-intervention skin tumor tissue will be compared between tumors receiving NK versus transforming growth factor betai cell injections.

Secondary Endpoints

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 criteria
Up to 8 weeks after biopsy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort I (UD expanded NK cells)EXPERIMENTALPatients 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.
Cohort II (UD expanded TGFbetai NK cells)EXPERIMENTALPatients 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.

Interventions

NameTypeDescription
Biopsy ProcedurePROCEDUREUndergo SOC biopsy
Natural Killer Cell TherapyBIOLOGICALGiven UD expanded NK cells intratumorally
Surgical ProcedurePROCEDUREUndergo SOC excision
Universal Donor Expanded TGF-beta-imprinted NK CellsBIOLOGICALGiven intratumorally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Frequently asked questions about Natural Killer Cell Therapy

What is Natural Killer Cell Therapy used for in Skin Basal Cell Carcinoma?

Natural Killer Cell Therapy is an investigational monoclonal antibody being studied for the treatment of Skin Basal Cell Carcinoma. It is administered through intratumoral injection and is currently in early Phase 1 clinical development. The therapy is being evaluated in a controlled trial with biomarker selection, though it is not yet approved.

Who makes Natural Killer Cell Therapy?

Johnson & Johnson (NYSE: JNJ) is developing Natural Killer Cell Therapy. The company is conducting a Phase 1 clinical trial for this investigational treatment targeting Skin Basal Cell Carcinoma. Johnson & Johnson is the sponsor of the ongoing study, which is currently recruiting participants in the United States.

What phase is Natural Killer Cell Therapy in?

Natural Killer Cell Therapy is in early Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing trial is actively recruiting participants and is designed as a controlled study with biomarker selection for the treatment of Skin Basal Cell Carcinoma.

What clinical trials is Natural Killer Cell Therapy in?

Natural Killer Cell Therapy is being studied in clinical trial NCT07144384, titled "Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer Cells for the Treatment of Skin Squamous Cell Carcinoma and Basal Cell Carcinoma." This early Phase 1 trial is recruiting 40 participants in the United States.

How does Natural Killer Cell Therapy work?

Natural Killer Cell Therapy is a monoclonal antibody designed to target and modulate natural killer cells. It is administered via intratumoral injection to treat Skin Basal Cell Carcinoma. The therapy is being evaluated for its ability to enhance the immune response against tumor cells, though the specific molecular target has not been disclosed.