CIML NK Cell in Head & Neck Cancer

STATUS

Recruiting
End date

Jun 1, 2023
participants needed

12
sponsor

Dana-Farber Cancer Institute

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Updated on 5 May 2022

See if I qualify

cancer

prednisone

neutrophil count

head and neck cancer

oropharyngeal

caries

combination drug

neck cancer

advanced head and neck cancer

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

Description

This is a two-part, non randomized, open label, single site Phase 1 study. The purpose of this research study is to obtain information on the safety and effectiveness of this combination of study drugs to treat advanced head and neck. The experimental combination therapy in this study involves CIML NK cells from a haploidentical donor (meaning cells from another person with similar immune proteins), IL-15, and participants in cohort 2 will also receive ipilimumab. CIML NK cells are an allogeneic cell product derived from qualified donor natural killer (NK) cells that have been bathed in special proteins to help to identify and treat certain advanced cancers.

Participants who fulfill eligibility criteria will be entered into the trial CTLA-4 Inhibition in Combination with Memory-like Natural Killer (NK) Cell Immune Cell Therapy in Advanced Head & Neck Cancer.

The study consists of 2 parts:

Cohort 1 CIML NK cells without ipilimumab
The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have advanced head and neck cancer, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated
Cohort 2 participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Cohort plus a lead-in dose of ipilimumab
It is expected that about 12 people will take part in this research study.

This research study is a Phase I clinical trial, which tests the safety of investigational drugs and tries to define the appropriate dose of the investigational drugs to use for further studies.

"Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as treatment for any disease.

The U.S. Food and Drug Administration (FDA) has not approved IL-15 as a treatment for any disease.

The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for your specific disease but it has been approved for other uses.

Details

Condition	Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma
Treatment	Ipilimumab, CIML NK Cell Infusion, Interleukin-15 Superagonist (N-803)
Clinical Study Identifier	NCT04290546
Sponsor	Dana-Farber Cancer Institute
Last Modified on	5 May 2022

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Eligibility		Yes	No	Not Sure
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 and men must agree to use adequate contraception (hormonal or
	barrier method of birth control; abstinence) prior to study entry and for the duration of
	study participation, and for up to 26 weeks after the last dose of all investigational
	products (up to 16 weeks after the last N-803 dose), in such a manner that the risk of
	pregnancy is minimized. Should a woman become pregnant or suspect she is pregnant while she
	or her partner is participating in this study, she should inform her treating physician
	immediately
	Willing to provide blood and tissue from diagnostic biopsy and at the time of surgery
	Participants must have normal organ and marrow function as defined below
	leukocytes ≥ 2,500/mcL
	absolute neutrophil count ≥ 1,000/mcL
	platelets ≥ 90,000/mcL
	total bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
	AST(SGOT)/ALT(SGPT) ≤ 3x institutional upper limit of normal
	creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels
	creatinine within normal institutional limits OR
	above institutional normal
	Oxygen saturation: ≥ 90% on room air
	Left ventricular ejection fraction (cardiac function) > 40%
Exclusion Criteria
	Patients with nasopharyngeal carcinoma are not eligible
	Participants who have had anti-tumor chemotherapy or other investigational agents
	within 2 weeks prior to cell infusion (6 weeks for nitrosoureas or mitomycin C), or
	Solid organ transplant (allograft) recipients
	immunotherapy within 3 weeks prior, or those who have not recovered from adverse
	Participants who are receiving any other investigational agents
	events due to agents administered more than 3 weeks prior
	History of allergic reactions attributed to compounds of similar chemical or biologic
	composition to N-803 or other agents used in study
	Participants with known brain metastases should be excluded from this clinical trial
	because of their poor prognosis and because they often develop progressive neurologic
	Known non-infectious pneumonitis or any history of interstitial lung disease
	dysfunction that would confound the evaluation of neurologic and other adverse events
	Autoimmune disease: patients with a history of inflammatory bowel disease, including
	Receipt of a live vaccine within 30 days of start of study treatment
	ulcerative colitis and Crohn disease, are excluded from this study, as are patients
	with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic
	progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
	vasculitis [Wegener's granulomatosis]) and motor neuropathy considered of autoimmune
	origin (e.g. Guillain- Barre syndrome and myasthenia gravis). Patients with Hashimoto
	thyroiditis are eligible
	Uncontrolled intercurrent illness including, but not limited to, ongoing or active
	infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
	arrhythmia, or psychiatric illness/social situations that would limit compliance with
	study requirements
	Pregnant women are excluded from this study because of the unknown teratogenic risk of
	CIML NK cells and N-803 and with the potential for teratogenic or abortifacient
	effects by fludarabine/cyclophosphamide chemotherapy regimen. Because there is an
	unknown but potential risk for adverse events in nursing infants secondary to
	treatment of the mother with CIML NK cells and N-803, breastfeeding should be
	discontinued if the mother is treated on this study
	HIV-positive participants are ineligible because of the potential for pharmacokinetic
	interactions with anti-retroviral agents used in this study. In addition, these
	participants are at increased risk of lethal infections when treated with
	marrow-suppressive therapy
	Individuals with active uncontrolled hepatitis B or C are ineligible as they are at
	high-risk of lethal treatment-related hepatotoxicity in the setting of marrow
	suppression

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CIML NK Cell in Head & Neck Cancer