A Study of Possibility of Using Regulatory T Cells(VT301) for Treatment of Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title: A Phase 1 Open-Label Dose-Escalating Study to Determine the Safety, and Tolerability of VT301 in Subjects With Mild-to-Moderate Alzheimer's Disease

Status Recruiting

Clinical Trial Summary

The overall study methods are as follows.

[Clinical Trials Schedules] The study consists of a screening period(Visit 1) of up to 30 to 50 days, blood collection visits(Visit 2) for IP generation and administration visits for IP administration(Visit 3), with a follow-up(FU) period of 90 days(Visit 4~7). During the Follow-up(FU) Period, subjects will visit 4 times for safety, tolerability and efficacy evaluation, with 90 Day being the End of Study(EOS) Visit.

[Subject screening and blood collection for IP generation] During Screening Period, subjects will be informed about the study and asked if they want to participate. The subjects and representatives and the caregiver/study partner will be asked to sign consent forms before any study-specific procedures are performed. Screening procedures will be performed to assess whether the subject is eligible to participate in the study. A minimum of approximately 200 mL of the subject's blood will be collected ≥30 days before Baseline and shipped to the IP Manufacturing Agency for generation of the IP. Subjects are required to refrain from consuming alcohol ≥3 days before any blood samples for IP generation are collected. If required (e.g. due to contamination), additional blood samples for IP generation may be collected during an unscheduled visit.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT05016427
• Study type: Interventional
• Source: VTBIO Co. LTD
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2020
• Completion date: April 1, 2022