NCT05541549

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cellevolve Bio Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Progressive Multifocal Leukoencephalopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-03-01
• Completion: 2025-04-01
• First posted: 2022-09-15
• Last updated: 2022-09-16

Regulatory

• FDA-regulated drug study