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COMPLETED
NCT04290546
PHASE1

CIML NK Cell in Head & Neck Cancer

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2020-07-20

Completion Date

2024-12-16

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

Interleukin-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.

BIOLOGICAL

CIML NK cell Infusion

(Dose 0 or -1) infused on Day 0

DRUG

Ipilimumab

single dose of lead-in ipilimumab via iv per protocol determined dose

DRUG

Cetuximab

Starting day +15, every 14 days for 8 total doses via IV per protocol

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States