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

NCT05541549 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-09-16

No results posted yet for this study

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.

Conditions

  • Progressive Multifocal Leukoencephalopathy

Interventions

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

Sponsors & Collaborators

  • Cellevolve Bio Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-03-31
Completion
2025-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541549 on ClinicalTrials.gov