Status:
COMPLETED
NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
NeoImmuneTech
Conditions:
Progressive Multifocal Leukoencephalopathy
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief 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 an...
Detailed Description
Study Description: This protocol will test whether NT-I7 is a viable strategy for promoting immune reconstitution in lymphopenic patients with PML. Twelve evaluable adults with PML and lymphopenia (C...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04781309
Start Date
May 5 2021
End Date
November 7 2025
Last Update
November 18 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892