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NT-I7 (Efineptakin alfa) for Head and Neck Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an active autoimmune disease such as lupus, rheumatoid arthritis, or multiple sclerosis.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I haven't had immune therapy in the last 6 weeks or chemo, radiation, or surgery in the last 4 weeks.I do not have any active infections like TB, Hepatitis, or HIV, and haven't been hospitalized in the last 4 weeks.I am 18 years old or older.I have pain from my cancer that isn't managed well.My cancer in the mouth or throat area is returning and can be removed with surgery.My spinal cord compression hasn't been fully treated with surgery or radiation.I can take care of myself but might not be able to do heavy physical work.I am HIV positive, on treatment, and my viral load is undetectable.I still have side effects from treatment over 4 weeks ago, except for hair loss, skin changes, nerve issues, or hormone imbalances treated with hormones.I have an autoimmune disease but only take low-dose steroids or topical steroids.My kidney function is within the safe range for the trial.My hepatitis B virus load is undetectable with treatment.I have another cancer type, but it won't affect this trial's treatment.I do not have any uncontrolled illnesses like heart failure or recent major health events.I have not had major surgery or a significant injury in the last 4 weeks.I am not pregnant or breastfeeding.I agree to use contraception during and for 3 months after the study.I haven't had any cancer except non-invasive types in the last 5 years.You are currently taking any experimental medications.
- Group 1: Treatment (efineptakin alfa)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are currently engaged in this investigation?
"Affirmative. The information on clinicaltrials.gov suggests this trial is still open for recruitment, with a start date of March 12th 2021 and the latest edit being July 7th 2022. Currently 10 people are sought to join from one medical centre."
Has Efineptakin alfa earned certification from the FDA?
"There is limited evidence to suggest the safety and efficacy of Efineptakin alfa, resulting in an estimative score of 1."
Have any other research projects explored the implications of Efineptakin alfa?
"Currently, there exists 11 ongoing studies into Efineptakin alfa with none of them at the Phase 3 level. Of those trials, 66 locations are running examinations on this medication, a majority of which located in Barcelona and Michigan."
Are there available spaces for enrolment in this research project?
"Reportedly, recruitment for this clinical trial is in progress. It was initially launched on March 12th 2021 and its official details were most recently amended on July 7th 2022."
Has a trial of this kind been conducted before?
"Since its initial trial in 2018, sponsored by NeoImmuneTech and involving 12 patients, Efineptakin alfa has received Phase 1 drug approval. At present, 11 trials are underway across 39 cities in 4 countries."
What is the purpose of this research endeavor?
"According to the trial sponsor, NeoImmuneTech, the primary endpoint of this clinical study is measuring participant completion rate over a period of up to 35 days after NT-I7 injection. Additionally, secondary outcomes will evaluate changes in immune subsets and phenotypes in peripheral blood as well as tumor infiltrating lymphocytes (TILs) present within tumour microenvironments before and after treatment with NT-I7."
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