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Experimental drug aims to rebuild immunity against rare brain infection

NCT ID NCT04781309

Disease control Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a drug called NT-I7 in 12 adults with progressive multifocal leukoencephalopathy (PML), a serious brain infection that occurs in people with weakened immune systems. The goal was to see if NT-I7 could increase the number of infection-fighting white blood cells (lymphocytes) to help control the virus. Participants received up to 3 injections and were followed for 12 to 19 months with blood tests, brain scans, and spinal taps.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

12 people

The number who actually took part.

Started

May 2021

Finished

Nov 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Adults (18 years of age or older) * Definite or Probable PML (2013 AAN Consensus Diagnostic Criteria) * CD4 and/or CD8 lymphopenia \<= 200 cells/dL that is not readily reversible within one month * Enrolled in 13-N-0017 * Ability to provide own consent at study entry * Ability to travel to NIH for study visits * Willingness to comply with all study procedures * If able to become pregnant or to father a child, patient must agree to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of the study EXCLUSION CRITERIA: * Age \< 18 years of age * Ongoing treatment with immune-suppressive medications (exception: topical steroid use and all forms of systemic steroids with durations less than 2 weeks) * History of immune-mediated disease affecting vital organ * Concurrent treatment with experimental therapies for PML that would interfere with or confound assessment of study outcomes * History of underlying autoimmune disease involving the CNS * Contraindication to any study procedures that would compromise ability to safely monitor the patient * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with study participation; or not in the best interest of the subject to participate, in the opinion of the treating investigator * Women who are pregnant or breastfeeding * Unwilling to have coded samples and/or data saved or used in other studies

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Conditions

The condition(s) this trial relates to.

progressive multifocal leukoencephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Progressive multifocal leukoencephalopathy

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.