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

First listed
Mar 2, 2020
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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