NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphope… (NCT04781309) | Clinical Trial Compass
CompletedEarly Phase 1
NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
United States12 participantsStarted 2021-05-05
Plain-language summary
Background:
Progressive multifocal leukoencephalopathy (PML) is a brain infection. It is caused by a virus. PML can happen in people with a weakened immune system. PML is associated with cognitive and visual impairment as well as motor and speech disturbances. There is no treatment for PML. Researchers want to see if a new drug can help.
Objective:
To see if the drug NT-I7 can help increase lymphocyte numbers, which may help control PML infection.
Eligibility:
Adults ages 18 and older with PML who are enrolled in Protocol #13-N-0017.
Design:
Participants will be screened under Protocol #13-N-0017.
Participants will have a 7-day inpatient stay, outpatient visits, and follow-up phone calls.
Participants will have a medical history and physical exam. They will give urine samples. Blood will be drawn from an arm vein or through an intravenous (IV) catheter.
Participants will get up to 3 doses of NT-I7. It will be given by injection into the muscle.
Participants will have lumbar punctures ( spinal taps ). A thin needle will be inserted into the spinal canal in the lower back. Cerebrospinal fluid will be removed. X-ray may be used to guide the procedure.
Participants will have magnetic resonance imaging (MRI) of the brain. The MRI scanner is a metal cylinder surrounded by a magnetic field. During MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get gadolinium, a contrast agent, through an IV catheter.
Participation will last for 12 to 19 months.
...
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the longitudinal change in absolute lymphocyte count over 6 months following study drug administration
Timeframe: over 6months following study drug administration
Trial details
NCT IDNCT04781309
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)