CIML NK Cell in Head & Neck Cancer (NCT04290546) | Clinical Trial Compass
CompletedPhase 1
CIML NK Cell in Head & Neck Cancer
United States11 participantsStarted 2020-07-20
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 carcinoma histologies)
* Any HPV status or smoking history is permitted. Oropharyngeal cancer patients are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory HPV PCR or ISH testing
* Available haploidentical donor that is willing and eligible for non-mobilized collection
* Prior exposure to a platinum-containing regimen (either in the definitive or advanced, recurrent/metastatic setting) and exposure to a PD-1/L1 inhibitor is required for SCCHN patients only
* Age 18 years or older
* ECOG performance status ≤ 2 (see Appendix A).
* No systemic corticosteroid therapy (≤ 10 mg of prednisone or equivalent dose of systemic steroids for non-autoimmune indications for at least 4 weeks prior to NK cell infusion).
* Ability to understand and the willingness to sign a written informed consent document.
* Negative pregnancy test for women of childbearing potential only. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
* The effects of CIML NK cells and N-803 on the developing human fetus are unknown.
For this reason, WOCBP…
What they're measuring
1
Rate of Dose Limiting Toxicity
Timeframe: first dose of study treatment up to 100 days