NCT06239220

PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC

A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Glenn J. Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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. PD-L1 t-haNK in combination with the immunotherapies, NAI and cetuximab, may work together to increase the activity and durability of the NK cells in fighting cancer cells. The U.S. Food and Drug Administration (FDA) has not approved PD-L1 t-haNK cells or NAI as a treatment for advanced head and neck cancer, but the FDA has approved cetuximab as a treatment option for advanced head and neck cancer. This trial will test these agents in combination. The research study procedures include screening for eligibility, study treatment visits, Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scans, blood tests, and electrocardiogram (ECGs). Participants will receive study treatment every 2 weeks for at least 1 year and will be followed for up to 15 years, as the FDA requires for any participant who has received genetically modified cells. It is expected that about 25 people will take part in this research study. ImmunityBio is supplying PD-L1 t-haNK and NAI for the study.

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

Type	Name	Description
BIOLOGICAL	PD-L1 t-haNK	Allogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol.
DRUG	Cetuximab	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.

Timeline

• Start date: 2024-02-16
• Primary completion: 2026-07-31
• Completion: 2027-01-31
• First posted: 2024-02-02
• Last updated: 2026-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study