A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML
- Conditions
- Progressive Multifocal Leukoencephalopathy
- Interventions
- Biological: CE-VST01-JC
- Registration Number
- NCT05541549
- Lead Sponsor
- Cellevolve Bio Inc
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CE-VST01-JC CE-VST01-JC - Placebo CE-VST01-JC -
- Primary Outcome Measures
Name Time Method To evaluate the effect of CE-VST01-JC on time to disease progression, as measured by mRS (modified Rankin Score) 1 year
- Secondary Outcome Measures
Name Time Method