Clinical Trials Directory

Trials / Completed

CompletedNCT04290546

CIML NK Cell in Head & Neck Cancer

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
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Dana-Farber Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGInterleukin-15 Superagonist (N-803)\-- Starting the day after (Cycle 1, Day +1) CIML NK-enriched cell infusion, at least 12 hours after CIML NK cell infusion is completed and up to 48 hours after CIML NK cell infusion, each participant will receive N-803 dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles). N-803 dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles) for cohorts 1 and 2, and 6 total doses in cohort 3. The dose should be calculated based on body weight at study entry, and recalculated only if greater than 10% change in weight.
BIOLOGICALCIML NK cell Infusion(Dose 0 or -1) infused on Day 0
DRUGIpilimumabsingle dose of lead-in ipilimumab via iv per protocol determined dose
DRUGCetuximabStarting day +15, every 14 days for 8 total doses via IV per protocol

Timeline

Start date
2020-07-20
Primary completion
2024-09-01
Completion
2024-12-16
First posted
2020-03-02
Last updated
2026-02-27

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04290546. Inclusion in this directory is not an endorsement.