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NT-I7 (Efineptakin alfa) for Head and Neck Cancer

Phase 1
Recruiting
Research Sponsored by Hyunseok Kang, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Age >= 18 years
Must not have
Has active autoimmune diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis
Has uncontrolled tumor-related pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 days after the nt-i7 injection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an immunotherapy drug to see if it can help the body fight cancer cells. The drug helps the body's immune system by boosting the T-cells that fight cancer.

Who is the study for?
Adults with recurrent squamous cell carcinoma of the head and neck, suitable for surgery, can join this trial. They must have proper liver and kidney function, no severe autoimmune diseases or recent major health events like heart failure. HIV-positive participants are eligible if their viral load is undetectable. Participants must not be pregnant or breastfeeding and agree to use contraception.
What is being tested?
The trial tests NT-I7 (Efineptakin alfa), an immunotherapy drug designed to boost T-cells in the immune system to better fight cancer cells. It's given to patients whose head and neck cancer has returned, alongside their surgical treatment.
What are the potential side effects?
Potential side effects of NT-I7 may include reactions related to boosting the immune system such as inflammation in various organs, flu-like symptoms, fatigue, possible auto-immune responses, and increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am 18 years old or older.
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My cancer in the mouth or throat area is returning and can be removed with surgery.
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I can take care of myself but might not be able to do heavy physical work.
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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active autoimmune disease such as lupus, rheumatoid arthritis, or multiple sclerosis.
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I have pain from my cancer that isn't managed well.
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I do not have any active infections like TB, Hepatitis, or HIV, and haven't been hospitalized in the last 4 weeks.
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My spinal cord compression hasn't been fully treated with surgery or radiation.
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I do not have any uncontrolled illnesses like heart failure or recent major health events.
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I am not pregnant or breastfeeding.
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I haven't had any cancer except non-invasive types in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 days after the nt-i7 injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 days after the nt-i7 injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who completed course of NT-I7
Proportion of treatment-related adverse events
Secondary study objectives
Body Weight Changes
Changes in Tumor infiltrating lymphocytes (TIL)
Changes in immune phenotyping
Other study objectives
Circulating cytokine analysis
Gene expression profiling: T cell receptor (TCR)
Gene expression profiling: ribonucleic acid (RNA)-sequencing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (efineptakin alfa)Experimental Treatment1 Intervention
Patients receive one dose of efineptakin alfa IM.

Find a Location

Who is running the clinical trial?

Hyunseok Kang, MDLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
NeoImmuneTechIndustry Sponsor
11 Previous Clinical Trials
553 Total Patients Enrolled

Media Library

Efineptakin alfa Clinical Trial Eligibility Overview. Trial Name: NCT04588038 — Phase 1
Oral Cancers Research Study Groups: Treatment (efineptakin alfa)
Oral Cancers Clinical Trial 2023: Efineptakin alfa Highlights & Side Effects. Trial Name: NCT04588038 — Phase 1
Efineptakin alfa 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588038 — Phase 1
~1 spots leftby Mar 2025
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