CIML NK Cell in Head & Neck Cancer

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    12
  • sponsor
    Dana-Farber Cancer Institute
Updated on 5 May 2022
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 IdentifierNCT04290546
SponsorDana-Farber Cancer Institute
Last Modified on5 May 2022

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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