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
This is a two-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, and participants in cohort 2 will also
receive ipilimumab. 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 2 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
It is expected that about 12 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
"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
The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for your specific
disease but it has been approved for other uses.
Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma
CIML NK Cell Infusion,
Interleukin-15 Superagonist (N-803)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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