A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system caused by JC polyomavirus (JCPyV) occurring in immunocompromised patients who face a disease that is usually progressive and often fatal (Padgett 1971; Tan 2010). Annually, it is estimated that 4,000 people develop PML in the United States and Europe combined (NORD 2015).

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. The study is designed to evaluate whether CE-VST01-JC infusions will slow and ultimately halt neurological progression in patients with PML compared with placebo as evaluated by modified Rankin Score (mRS).

Conditions

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Progressive Multifocal Leukoencephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

CE-VST01-JC

Intervention Type BIOLOGICAL

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-JC

Group Type EXPERIMENTAL

CE-VST01-JC

Intervention Type BIOLOGICAL

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

Interventions

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CE-VST01-JC

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No