CIML NK Cell in Head & Neck Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 20, 2020

Primary Completion Date

September 1, 2024

Study Completion Date

December 16, 2024

Conditions
Squamous Cell Carcinoma of the Head and NeckRecurrent Head and Neck Squamous Cell Carcinoma
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

Trial Locations (1)

02115

Dana Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Altor BioScience

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Miltenyi Biomedicine GmbH

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER