Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06239220
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
Sponsor:
Glenn J. Hanna
Organization:
Study Overview
Official Title:
A Phase 2 Trial of PD-L1 t-haNK, N-803 IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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), N-803 (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)
* N-803 (a type of recombinant human superagonist)
* Cetuximab (a type of antibody)
The names of the therapies involved in this study are:
* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)
* N-803 (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), N-803 (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, N-803 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 N-803 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 N-803 for the study.
The U.S. Food and Drug Administration (FDA) has not approved PD-L1 t-haNK cells or N-803 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 N-803 for the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: