PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
NCT06239220 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-02-27
Summary
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
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
- Metastatic Head and Neck Cancer
- Recurrent Head and Neck Cancer
- Metastatic Head-and-neck Squamous-cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
Interventions
- BIOLOGICAL
-
PD-L1 t-haNK
Allogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol.
- DRUG
-
Epidermal growth factor receptor, via intravenous (into the vein) infusion per institutional standard of care.
- BIOLOGICAL
-
NAI
Recombinant human superagonist, via subcutaneous injection (under the skin) per protocol.
Sponsors & Collaborators
-
ImmunityBio, Inc.
collaborator INDUSTRY -
Glenn J. Hanna
lead OTHER
Principal Investigators
-
Glenn J Hanna, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-16
- Primary Completion
- 2026-07-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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