Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05541549
Other study ID # 20210001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date February 2023
Est. completion date April 2025

Study information

Verified date September 2022
Source Cellevolve Bio Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 2025
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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).

Study Design


Related Conditions & MeSH terms

  • Leukoencephalopathies
  • Leukoencephalopathy, Progressive Multifocal
  • Progressive Multifocal Leukoencephalopathy

Intervention

Biological:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cellevolve Bio Inc

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the effect of CE-VST01-JC on time to disease progression, as measured by mRS (modified Rankin Score) 1 year
See also
  Status Clinical Trial Phase
Terminated NCT01211639 - Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy N/A
Completed NCT02004444 - JC Virus Reactivation in Multiple Sclerosis N/A
Recruiting NCT05849467 - Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy Phase 1
Recruiting NCT01730131 - Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Recruiting NCT04781309 - NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy Early Phase 1
Completed NCT02694783 - Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy With Ex Vivo Generated Polyomavirus-Specific T-Cells Early Phase 1
Completed NCT01132053 - Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)
Completed NCT03399981 - Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
Terminated NCT00746941 - Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML) Phase 1/Phase 2
Completed NCT02895581 - Retrospective Study of the Survival of Patients Suffering From Hiv-related Progressive Multifocal Leukoencephalopathy N/A
Recruiting NCT04453917 - Dynamics of T Cell Expression of Immune Checkpoint Molecules in Progressive Multifocal Leukoencephalopathy N/A
Recruiting NCT04091932 - Treatment of PD-1 Inhibitor in AIDS-associated PML Phase 2
Not yet recruiting NCT06276504 - Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection Phase 2/Phase 3