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

Progressive Multifocal Leukoencephalopathy Clinical Trial

Official title:
ASCEND-JC: A Multi-center, Randomized, Double-blind, Phase 2 Study, Evaluating JCPyV-specific T Cell Therapy for the Treatment of PML

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

  • Leukoencephalopathies
  • Leukoencephalopathy, Progressive Multifocal
  • Progressive Multifocal Leukoencephalopathy
Clinical Trial Details
NCT number NCT05541549
Study type Interventional
Source Cellevolve Bio Inc
Contact
Status Not yet recruiting
Phase Phase 2
Start date February 2023
Completion date April 2025
View Details
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