Combination Immunotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byGlenn Hanna, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Glenn Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with advanced head and neck cancer, including oral cavity or salivary gland carcinoma, who've had platinum-based treatment and PD-1/L1 inhibitor therapy. They must have good organ function, no severe allergies to study drugs, not be pregnant or breastfeeding, agree to contraception use during the trial and for some time after. Excludes those with nasopharyngeal carcinoma, recent other treatments or uncontrolled illnesses.

Inclusion Criteria

leukocytes ≥ 2,500/mcL

My heart pumps well, with an ejection fraction over 40%.

Oxygen saturation: ≥ 90% on room air

See 18 more

Exclusion Criteria

I have received an organ transplant from another person.

Participants who are receiving any other investigational agents

I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis, but I can have Hashimoto's thyroiditis.

See 10 more

Treatment Details

Interventions

Cetuximab (Monoclonal Antibodies)
CIML NK cell Infusion (CAR T-cell Therapy)
Interleukin-15 Superagonist (N-803) (Cytokine)
Ipilimumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing a combination of CIML NK donor cells (a type of immune cell), IL-15 superagonist (boosts immune response), Ipilimumab and Cetuximab (cancer-targeting drugs) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It aims to assess safety and effectiveness.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort I without Ipilimumab Lead inExperimental Treatment2 Interventions

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).

Group II: Cohort 3 with Cetuximab InfusionsExperimental Treatment3 Interventions

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.

Group III: Cohort 2 with Ipilimumab Lead InExperimental Treatment3 Interventions

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.