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Recombinant human IL-7-hyFc (NT-I7) for Colorectal Cancer
Study Summary
This trial is testing a new drug, NT-I7, to see if it can help boost the immune system in older cancer survivors. Eligible participants must be 60 or older, and have recently finished chemotherapy for breast, colorectal, or bladder cancer.
- Colorectal Cancer
- Bladder Cancer
- Breast 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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- You have advanced stage gastrointestinal cancer that has been treated with surgery and chemotherapy or chemoradiation.You have received Hepatitis A or B vaccines in the past, or have had a previous infection of Hepatitis A or B.You are allergic to latex.You have had Guillain-Barre syndrome within six weeks after receiving a previous vaccine that contains tetanus toxoid.You have a serious heart condition.You have had breast cancer that was treated with chemotherapy, surgery, and/or radiation therapy.You are currently taking any experimental medications for other studies.You have a heart condition called atrio-ventricular block, which is more severe than the first degree, and you do not have a pacemaker.You have an enlarged spleen or a history of a blood disorder that causes the excessive production of blood cells.You have experienced a severe allergic reaction to any vaccines in the past.You have a history of an irregular heartbeat in the lower chambers of your heart.We don't know if NT-I7 is safe for unborn babies. So, if you are pregnant, you cannot participate in the study.
- Group 1: 1/ Arm 1
- Group 2: 2/ Arm 2a
- Group 3: 3/ Arm 2b
- 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
What is the total capacity of subjects being recruited for this clinical trial?
"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing and began on December 1st 2022. The study was recently updated on November 25th of the same year; it seeks 68 volunteers across a single site."
Is recruitment for this trial ongoing?
"Verified. The information on clinicaltrials.gov states that this trial is actively searching for appropriate candidates to participate in it. It was initially made available on December 1st 2022 and has been updated recently, the 25th of November 2022. 68 volunteers need to be recruited from one single medical centre."
Has this trial been conducted previously or is it the inaugural exploration of its kind?
"Since its initial study in 2018, led by NeoImmuneTech and involving 12 participants, Recombinant human IL-7-hyFc (NT-I7) has been granted Phase 1 drug approval. Currently there are 11 ongoing trials for this compound spread across 39 cities within 4 countries."
Has the FDA granted permission for Recombinant human IL-7-hyFc (NT-I7) to be used in clinical practice?
"Based on our team's assessment, Recombinant human IL-7-hyFc (NT-I7) is deemed to have a safety rating of 1 given that it is still in its first trial phase with limited evidence supporting both efficacy and security."
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