CIML NK Cell in Head & Neck Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04290546
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interleukin-15 Superagonist (N-803) — DRUG
    \-- 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 — BIOLOGICAL
    (Dose 0 or -1) infused on Day 0
  • Ipilimumab — DRUG
    single dose of lead-in ipilimumab via iv per protocol determined dose
  • Cetuximab — DRUG
    Starting day +15, every 14 days for 8 total doses via IV per protocol

Study Details

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

Key Dates

Start date
Jul 20, 2020
Status verified
Jun 2026
Primary completion
Sep 1, 2024
Completion
Dec 16, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I without Ipilimumab Lead in
    Haploidentical donor derived CIML NK cell infusion with subcutaneous N-803 for eligible patients with platinum-refractory and immune checkpoint blockade-refractory, advanced head and neck squamous cell carcinoma (Cohort 1) * CIML NK cell infusion (Dose 0 or -1) infused on Day 0. * Interleukin-15 Superagonist dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles).
  • Experimental: Cohort 2 with Ipilimumab Lead In
    Cohort 2 treated with an ipilimumab lead-in prior to CIML NK cell infusion after safety is established with the NK cell and N-803 treatments alone. * Participants in the ipilimumab subgroup (Cohort 2) will receive a single dose of lead-in ipilimumab via iv per protocol determined dose followed by lymphodepleting chemotherapy on Day -6 for a total of 5-days, prior to receiving CIML NK cell infusion. * CIML NK cell infusion-Highest Dosed per cohort 1, infused on day 0 * Interleukin-15 Superagonist (N-803) Administration \-- dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles). * Cohort 2 will receive the highest number of CIML NK cells that is still considered safe and ipilimumab.
  • Experimental: Cohort 3 with Cetuximab Infusions
    Cohort 3 treated with CIML NK cell infusion after safety is established with the NK cell and N-803 treatments alone, followed by cetuximab infusions. * \- Participants in cetuximab subgroup (Cohort 3) will receive lymphodepleting chemotherapy on Day -6 for a total of 5-days, prior to receiving CIML NK cell infusion. * CIML NK cell infusion-Highest Dosed per cohort 1, infused on day 0 * Interleukin-15 Superagonist (N-803) Administration \-- dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles). * Cetuximab Administration --dosed at 500mg/m2 IV over 120 minutes for the first dose, then over 60 minutes for subsequent doses. This will be infused every 14 days for 8 doses started on day +15. * Cohort 3 will receive the highest number of CIML NK cells that is still considered safe and ipilimumab.

Primary Outcome Measure

Rate of Dose Limiting Toxicity [ Time Frame: first dose of study treatment up to 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-

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By research site
Dana Farber Cancer Institute· Boston, MA

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