RecruitingPhase 2NCT06239220

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)


Sponsor

Glenn J. Hanna

Enrollment

25 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — PD-L1 t-haNK cells, NAI IL-15sa, and cetuximab — for people with head and neck squamous cell carcinoma (HNSCC) that has returned or spread and cannot be cured surgically. These are cancers of the mouth, throat, voice box, or nasal cavity that have not responded to prior treatments. **You may be eligible if...** - You have confirmed recurrent or metastatic head and neck squamous cell carcinoma from any site in the head or neck - You have at least one measurable tumor on scans - You have received 1–2 prior treatments for recurrent/metastatic disease, including at least one anti-PD-1/PD-L1 immunotherapy - You are 18 or older - You have documentation of your tumor's PD-L1 expression level **You may NOT be eligible if...** - You have had more than 2 prior treatments for your recurrent/metastatic disease - You have not yet recovered from side effects of prior therapy - Your performance status or organ function does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPD-L1 t-haNK

Allogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol.

DRUGCetuximab

Epidermal growth factor receptor, via intravenous (into the vein) infusion per institutional standard of care.

BIOLOGICALNAI

Recombinant human superagonist, via subcutaneous injection (under the skin) per protocol.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06239220


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