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A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML (ASCEND-JC)

Primary Purpose

Progressive Multifocal Leukoencephalopathy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CE-VST01-JC
Sponsored by
Cellevolve Bio Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Multifocal Leukoencephalopathy focused on measuring VST, Virus specific T-Cell, cell therapy, PML, JC virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    CE-VST01-JC

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2022
    Last Updated
    September 14, 2022
    Sponsor
    Cellevolve Bio Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05541549
    Brief Title
    A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML
    Acronym
    ASCEND-JC
    Official Title
    ASCEND-JC: A Multi-center, Randomized, Double-blind, Phase 2 Study, Evaluating JCPyV-specific T Cell Therapy for the Treatment of PML
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cellevolve Bio Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Progressive Multifocal Leukoencephalopathy
    Keywords
    VST, Virus specific T-Cell, cell therapy, PML, JC virus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    CE-VST01-JC
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    CE-VST01-JC
    Intervention Description
    CE-VST01-JC at a dose of 1 × 10^8 cells administered as an intravenous (IV) infusion every 28 days for 4 total infusions
    Primary Outcome Measure Information:
    Title
    To evaluate the effect of CE-VST01-JC on time to disease progression, as measured by mRS (modified Rankin Score)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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