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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
Must not have
History of underlying autoimmune disease involving the CNS
Women who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6months following study drug administration
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My CD4 or CD8 cell count is 200 or less and can't be quickly fixed.
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I can travel to NIH for study visits.
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I can make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease that affects my brain or spinal cord.
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I am not pregnant or breastfeeding.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6months following study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6months following study drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
the longitudinal change in absolute lymphocyte count over 6 months following study drug administration
Secondary study objectives
Change in lymphocyte subsets, including CD4, CD8, and CD19 positive cells
Disease course
Safety

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: NT-I7Experimental Treatment1 Intervention
480 microgram/kg IM (initial dose)

Find a Location

Who is running the clinical trial?

NeoImmuneTechIndustry Sponsor
11 Previous Clinical Trials
551 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,378 Previous Clinical Trials
652,180 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

NT-I7 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04781309 — Phase < 1
Progressive Multifocal Leukoencephalopathy Research Study Groups: NT-I7
Progressive Multifocal Leukoencephalopathy Clinical Trial 2023: NT-I7 Highlights & Side Effects. Trial Name: NCT04781309 — Phase < 1
NT-I7 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04781309 — Phase < 1
~3 spots leftby Jan 2026
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