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NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy

NCT04781309 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-18

No results posted yet for this study

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.

...

Conditions

  • Progressive Multifocal Leukoencephalopathy

Interventions

DRUG

NT-I7

NT-I7 is a recombinant human interleukin-7 fused to a hybrid fragment crystallizable region of a human antibody (hyFc). NT-I6 has a molecular weight of 104 kD. The active moiety of NT-I7 is recombinant human interleukin-7 (rhIL-7), containing human IL-7 (amino acids 4 through 155) and exhibiting all known functions of endogenous human IL-7.

Sponsors & Collaborators

  • NeoImmuneTech

    collaborator INDUSTRY

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Irene CM Cortese, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2025-11-07
Completion
2025-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781309 on ClinicalTrials.gov