Your session is about to expire
← Back to Search
Cytokine
NT-I7 for Progressive Multifocal Leukoencephalopathy
Phase < 1
Recruiting
Led By Irene CM Cortese, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CD4 and/or CD8 lymphopenia less than or equal to 200 cells/dL from any cause that is not readily reversible within one month
Ability to travel to NIH for study visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6months following study drug administration
Awards & highlights
Study Summary
This trial will test whether NT-I7 can help people with PML by increasing lymphocyte numbers.
Who is the study for?
Adults over 18 with Progressive Multifocal Leukoencephalopathy (PML) and low lymphocyte counts, enrolled in Protocol #13-N-0017. Participants must be able to travel for study visits, provide consent, follow procedures, and use reliable birth control if applicable. Excludes those on immune-suppressive meds (except short-term steroids), with autoimmune CNS diseases or conditions that could affect the trial.Check my eligibility
What is being tested?
The trial is testing NT-I7, a new drug designed to boost lymphocyte numbers which may help fight PML infection. It involves an initial 7-day hospital stay followed by outpatient visits and phone calls for up to 19 months. Procedures include injections of NT-I7 into the muscle, lumbar punctures, blood draws, urine samples, and MRI scans with contrast agents.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from injections into the muscle; risks associated with lumbar punctures like back pain or headache; reactions to gadolinium used in MRIs; plus any general drug-related side effects such as allergic reactions or changes in blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CD4 or CD8 cell count is 200 or less and can't be quickly fixed.
Select...
I can travel to NIH for study visits.
Select...
I can make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 6months following study drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6months following study drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
the longitudinal change in absolute lymphocyte count over 6 months following study drug administration
Secondary outcome measures
Change in lymphocyte subsets, including CD4, CD8, and CD19 positive cells
Disease course
Safety
Trial Design
1Treatment groups
Experimental Treatment
Group I: NT-I7Experimental Treatment1 Intervention
480 microgram/kg IM (initial dose)
Find a Location
Who is running the clinical trial?
NeoImmuneTechIndustry Sponsor
10 Previous Clinical Trials
495 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,340 Previous Clinical Trials
649,352 Total Patients Enrolled
Irene CM Cortese, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
5 Previous Clinical Trials
799 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving experimental treatments for PML that could affect the study results.My CD4 or CD8 cell count is 200 or less and can't be quickly fixed.I am 18 years old or older.You have been diagnosed with a specific brain infection called PML using specific criteria from 2013.I have an autoimmune disease that affects my brain or spinal cord.I am not pregnant or breastfeeding.I can travel to NIH for study visits.I am under 18 years old.I am not on long-term immune-suppressive medications, except for short-term steroids or topical steroids.I can make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: NT-I7
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are contributing to this research endeavor?
"Affirmative. Clinicaltrials.gov data indicates the recruitement of 12 participants at a single site for this clinical trial, which was first posted on May 5th 2021 and most recently updated on December 5th 2022."
Answered by AI
Are there any additional investigations regarding NT-I7?
"Currently, 11 clinical trials are investigating NT-I7 with none of them in the third phase. These investigations are mainly taking place in Barcelona and Texas as well as a few other sites totaling 66 locations overall."
Answered by AI
Has this kind of trial ever been attempted before?
"Since 2018, NeoImmuneTech has been researching NT-I7 and it's potential applications. The first Phase 1 trial of the drug took place in 2018 with 12 participants and was successfully approved for further exploration. Today 11 distinct trials are occurring across 39 urban centres located in 4 different nations."
Answered by AI
Is enrollment for this research experiment ongoing?
"Affirmative. The clinicaltrial.gov website confirms that this medical trial, first published on May 5th 2021 is actively accepting candidates. There are 12 patient spots available at 1 site hosting the study."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger