11
Participants
Start Date
July 20, 2020
Primary Completion Date
September 1, 2024
Study Completion Date
December 16, 2024
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."
CIML NK cell Infusion
(Dose 0 or -1) infused on Day 0
Ipilimumab
single dose of lead-in ipilimumab via iv per protocol determined dose
Cetuximab
Starting day +15, every 14 days for 8 total doses via IV per protocol
Dana Farber Cancer Institute, Boston
Collaborators (3)
Altor BioScience
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Miltenyi Biomedicine GmbH
INDUSTRY
Dana-Farber Cancer Institute
OTHER