NCT05541549

Brief Summary

This is a randomized, double-blinded, Phase 2 trial in patients with PML due to JCPyV. Patients will receive treatment with a matched virus-specific T-cell product (CE VST01-JC) or placebo, and will then be monitored for response to therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 13, 2022

Last Update Submit

September 14, 2022

Conditions

Progressive Multifocal Leukoencephalopathy

Keywords

VSTVirus specific T-Cellcell therapyPMLJC virus

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of CE-VST01-JC on time to disease progression, as measured by mRS (modified Rankin Score)

    1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Biological: CE-VST01-JC

CE-VST01-JC

EXPERIMENTAL
Biological: CE-VST01-JC

Interventions

CE-VST01-JCBIOLOGICAL

CE-VST01-JC at a dose of 1 × 10\^8 cells administered as an intravenous (IV) infusion every 28 days for 4 total infusions

CE-VST01-JCPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Male or female subjects aged 18 years or older, with actively progressing PML confirmed by MRI and JCPyV present in CSF or in brain biopsy tissue (diagnosis confirmed according to algorithm diagnostic criteria for PML developed by the American Academy of Neurology).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal

Condition Hierarchy (Ancestors)

Encephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesPolyomavirus InfectionsDNA Virus InfectionsSlow Virus DiseasesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukoencephalopathiesDemyelinating DiseasesNeuroinflammatory Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

February 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2025

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share