Trial · NCT04781309
NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
NCT04781309, Early phase 1, Completed, National Institute of Neurological Disorders and Stroke (NINDS)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy. Trials, record NCT04781309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04781309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
- NCT number
- NCT04781309
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- Progressive Multifocal Leukoencephalopathy
- Interventions
- NT-I7
- First posted
- 2021-03-04
- Last updated
- 2025-11-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the longitudinal change in absolute lymphocyte count over 6 months following study drug administration | over 6months following study drug administration | determine the kinetics and magnitude of effect of NT-I7 on absolute lymphocyte counts (ALC) in patients with PML and underlying lymphopenia from various causes, in order to inform appropriate design of a future study |
| Secondary | Safety | at each study timepoint | assessed by the occurrence of treatment-related adverse events. These adverse events will be tabulated separately by timepoint to identify any trends in the data and will be described using number and percent. |
| Secondary | Change in lymphocyte subsets, including CD4, CD8, and CD19 positive cells | at each study timepoint | These values will be investigated first descriptively at each timepoint using mean and SD or median and IQR, and then graphically. Key comparisons of interest will include baseline to Month 3 and baseline to Month 6. |
| Secondary | Disease course | at each study timepoint | These endpoints include quantification of JCV DNA in CSF and blood, change in Modified Rankin Scale score, change in Karnofsky Performance Scale score, change in PML lesion extension, change in pattern of contrast enhancement by brain MRI and survival. Key comparisons of interest will include baseline to Month 3 and baseline to Month 6. Here, the goal is to provide some initial proof of principle that the disease course is being impacted in a measurable way, particularly beyond Month 3. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04781309
GET https://conductscience.org/api/trials/v1/NCT04781309/registered