Actively Recruiting
A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist, and Cetuximab for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Glenn J. Hanna · Updated on 2026-02-27
25
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
G
Glenn J. Hanna
Lead Sponsor
I
ImmunityBio, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving PD-L1 t-haNK (a modified immune cell therapy), NAI (a protein that stimulates the immune system), and cetuximab (a targeted antibody) in adults with advanced head and neck cancer. This Phase 2 trial focuses on patients with recurrent, metastatic, or locoregionally advanced head and neck squamous cell carcinoma that cannot be surgically removed or cured. The study aims to see how these therapies work together to boost natural killer cell activity against cancer cells. Participants will receive doses of PD-L1 t-haNK through intravenous infusion, NAI via under-the-skin injections, and cetuximab intravenously every two weeks in 28-day cycles. Dose adjustments may occur if side effects arise, with participants starting at standard dose levels and potentially lowering doses as needed. The study includes a baseline visit, imaging scans every eight weeks, treatment every 14 days, an end-of-treatment assessment, and follow-up visits every 3 to 4 months for up to three years, with longer-term follow-up every 6 to 12 months for up to 15 years to monitor long-term effects. During the study, participants undergo CT, MRI, and PET scans to track tumor response, along with blood tests and electrocardiograms to monitor safety. Researchers will measure the tumor's response rate over approximately one year, as well as treatment-related toxicity, duration of response, progression-free survival, and overall survival up to three years. The extended follow-up of up to 15 years is required for participants receiving genetically modified cells, ensuring long-term safety monitoring.
CONDITIONS
Brief Title
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with head and neck squamous cell carcinoma that is recurrent, metastatic, or locally advanced and cannot be removed by surgery
- Have at least one measurable tumor lesion of 1 cm or more by CT or MRI
- Have received 1 or 2 prior systemic treatments for recurrent or metastatic disease, with one including anti-PD-1 or PD-L1 therapy
- Have documented tumor PD-L1 expression and HPV status if available
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as defined by specific blood count and liver and kidney test levels
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and 120 days after treatment
- Able and willing to provide written informed consent
You will not qualify if you...
- Previously treated with 3 or more lines of systemic therapy for recurrent or metastatic head and neck cancer
- Received radiation therapy within 10 days prior to starting study treatment
- Have had a solid organ transplant
- Have active brain metastases or carcinomatous meningitis, unless stable and off steroids for at least 3 weeks
- History of significant autoimmune disease requiring corticosteroids or active therapy
- Uncontrolled illnesses such as active infections or recent serious heart problems
- Have another active cancer requiring treatment, except certain skin cancers or in situ cervical cancer
- Positive test for hepatitis B or C virus (except if hepatitis C RNA negative)
- Pregnant, breastfeeding, or planning pregnancy or fatherhood during study and 120 days after
- Women unwilling to use two methods of contraception during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 1 year
Participants receive study treatment with PD-L1 t-haNK, NAI, and cetuximab every 2 weeks for at least 1 year. Imaging scans such as CT, MRI, and PET scans are performed every 8 weeks to evaluate the disease.
Visits every 2 weeks for treatment and imaging scans every 8 weeks
Duration - Up to 15 years
After treatment ends, participants are followed for safety and disease status every 3 to 4 months for up to 3 years, then every 6 to 12 months for up to 15 years as required by the FDA for genetically modified cell therapy.
Follow-up visits every 3 to 4 months for up to 3 years, then every 6 to 12 months up to 15 years
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
G
Glenn J Hanna, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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