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Also known as Interleukin-15 Superagonist (N-803)
Interleukin-15 Superagonist · 1 trial · 2 indications
All patients receiving any dose of study treatment will be evaluated for safety. DLTs overall and by dose level will be reported as proportions with 90% exact binomial confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Cohort I without Ipilimumab Lead in | EXPERIMENTAL | 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). |
| Cohort 2 with Ipilimumab Lead In | EXPERIMENTAL | 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. |
| Cohort 3 with Cetuximab Infusions | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Histologically or cytologically confirmed, recurrent or metastatic squamous cell carcinoma of the head neck (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses) or salivary gland carcinoma (including adenoid cystic carcinoma and non-adenoid cystic carcin...
Interleukin-15 Superagonist is being studied for squamous cell carcinoma of the head and neck, including recurrent head and neck squamous cell carcinoma. It is an oncology asset in clinical development and is not approved for any indication. The only recorded trial enrolled 11 patients with these head and neck cancer types in the United States.
Interleukin-15 Superagonist targets IL2RG, IL2RB, and IL15RA and acts as an agonist at those receptors. By activating this receptor complex, it is designed to stimulate immune cell signaling. The molecule is described as a small molecule agonist directed at the interleukin-15 receptor subunits.
Interleukin-15 Superagonist is being developed by ImmunityBio, Inc., which trades under the ticker IBRX. ImmunityBio is the sponsor associated with the clinical program for this agent in head and neck cancer.
Interleukin-15 Superagonist is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial in head and neck cancer has completed, and no active trials of this agent are currently listed.
Interleukin-15 Superagonist has been evaluated in one completed Phase 1 trial, NCT04290546, titled CIML NK Cell in Head & Neck Cancer. That trial enrolled 11 participants in the United States, included adults 18 years and older of all sexes, and did not enroll healthy volunteers.
Yes, Interleukin-15 Superagonist is also known as Interleukin-15 Superagonist (N-803). The two names refer to the same agent, so searches for N-803 in head and neck cancer point to this same ImmunityBio program.