Actively Recruiting
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
Led by Glenn J. Hanna · Updated on 2026-02-27
25
Participants Needed
2
Research Sites
154 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
The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: * PD-L1 t-haNK cell therapy (a NK cell therapy infusion) * NAI (a type of recombinant human superagonist) * Cetuximab (a type of antibody)
CONDITIONS
Official Title
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed diagnosis of head and neck squamous cell carcinoma with recurrent, metastatic, or advanced incurable disease from any mucosal subsite
- Have at least one measurable lesion by CT or MRI scans
- Have received 1 or 2 prior systemic therapy lines for recurrent/metastatic disease, including anti-PD-1/L1 therapy
- Be 18 years or older
- Provide prior tumor PD-L1 and HPV status if available
- Have performance status of 0 or 1 on the ECOG scale
- Have adequate organ and marrow function within 14 days prior to registration
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to registration
- Agree to use contraception during the study and for 120 days after last dose (female participants should not breastfeed)
You will not qualify if you...
- Have had 3 or more lines of systemic therapy for recurrent/metastatic disease
- Have received radiation therapy within 10 days before starting treatment
- Are solid organ transplant recipients
- Have active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Have significant autoimmune disease requiring active treatment including corticosteroids over 10 mg daily
- Have uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, recent stroke, or ventricular arrhythmia within 6 months
- Have progressing additional cancers requiring treatment (except certain skin or cervical cancers)
- Have positive tests for hepatitis B or C viruses indicating infection (HIV positive allowed if viral load is undetectable)
- Are pregnant, breastfeeding, or planning to conceive/father children during the study and up to 120 days after last dose
- Women must use two contraception methods during the trial
AI-Screening
AI-Powered Screening
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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
CONTACT
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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