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 range18 Years – 120 Years

SexALL

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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…

What they're measuring

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)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-11-07