A Study of Possibility of Using Regulatory T Cells(VT301) for Treatment of Alzheimer's Disease
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.
Timeline
- Start
- 2020-11-01
- Primary completion
- 2021-11-01
- Completion
- 2022-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VT301 | Cell therapy | 85000 cells/kg | Intravenous |
| Subject | VT301 | Cell therapy | 170000 cells/kg | Intravenous |