CIML NK Cell in Head & Neck Cancer

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title: A Phase 1 Trial of CTLA-4 Inhibition, With or Without Cetuximab, and in Combination With Memory-like Natural Killer (NK) Cell Immune Cell Therapy in Advanced Head & Neck Cancer

Status Recruiting

Clinical Trial Summary

This research study is evaluating the safety and efficacy of a combination drug and biologic therapy in patients with advanced head and neck cancer. This research study involves the following drugs and biologics: - CIML NK donor cells - IL-15 superagonist - Ipilimumab - Cetuximab

Clinical Trial Description

This is a three-part, non randomized, open label, single site Phase 1 study. The purpose of this research study is to obtain information on the safety and effectiveness of this combination of study drugs to treat advanced head and neck. The experimental combination therapy in this study involves CIML NK cells from a haploidentical donor (meaning cells from another person with similar immune proteins), IL-15, participants in cohort 2 will also receive ipilimumab, and participants in cohort 3 will receive cetuximab. CIML NK cells are an allogeneic cell product derived from qualified donor natural killer (NK) cells that have been bathed in special proteins to help to identify and treat certain advanced cancers. - Participants who fulfill eligibility criteria will be entered into the trial CTLA-4 Inhibition in Combination with Memory-like Natural Killer (NK) Cell Immune Cell Therapy in Advanced Head & Neck Cancer. The study consists of 3 parts: - Cohort 1 CIML NK cells without ipilimumab - The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have advanced head and neck cancer, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated - Cohort 2 participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Cohort plus a lead-in dose of ipilimumab - Cohort 3 participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Cohort plus infusions of cetuximab - It is expected that about 25 people will take part in this research study. This research study is a Phase I clinical trial, which tests the safety of investigational drugs and tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved IL-15 as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for your specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved cetuximab for your specific disease. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Recurrent Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

• NCT number: NCT04290546
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Glenn Hanna, MD
• Phone: (617) 632-3090
• Email: Gjhanna@partners.org
• Status: Recruiting
• Phase: Phase 1
• Start date: July 20, 2020
• Completion date: July 1, 2024