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CIML NK Cell in Head & Neck Cancer

NCT04290546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-02-27

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

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.

BIOLOGICAL

CIML NK cell Infusion

(Dose 0 or -1) infused on Day 0

DRUG

Ipilimumab

single dose of lead-in ipilimumab via iv per protocol determined dose

DRUG

Cetuximab

Starting day +15, every 14 days for 8 total doses via IV per protocol

Sponsors & Collaborators

Principal Investigators

  • Glenn Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2024-09-01
Completion
2024-12-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290546 on ClinicalTrials.gov