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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
VT301 is off-white suspension of regulatory T cells (Tregs) (1.7x10\^5 cells/kg±15%) for injection diluted with sterile saline solution and supplied in clear, colorless, polypropylene vials.
Vtbio Co., Ltd
Seoul, South Korea
RECRUITINGAll Adverse Events(AE) that occurred from the time of acquisition of consent of the subjects to the time of EOS(End of Study) shall be collected.
The collected AE (or ADR) should be monitored until possible recovery (or the investigator is determined to be normalized) or until the EOS can be determined to be meaningless for further monitoring.
Time frame: Change from Baseline AE at 3 months
Number of subjects with abnormal clinical Physical examination
The number of subjects with normal and abnormal Physical examination findings will be summarized for each treatment group at each time point. Clinical significance was determined by the investigator.
Time frame: Change from Baseline Physical examination at 3 months
Number of subjects With Clinically Significant Abnormalities in 12-lead Electrocardiogram
The number of subjects with normal and abnormal ECG findings will be summarized for each treatment group at each time point. Clinical significance was determined by the investigator. ECG measures PR interval (ms), QRS interval, QT interval(ms), QTc interval (ms), and heart rate(bpm) for each treatment group at each time point.
Time frame: Change from Baseline 12-lead Electrocardiogram at 3 months
Number of subjects with abnormal clinical Laboratory Tests
The number of subjects with normal and abnormal Laboratory Tests findings will be summarized for each treatment group at each time point. Clinical significance was determined by the investigator. Blood and urine samples will be collected for the assessment of following clinical Laboratory Tests
Time frame: Change from Baseline clinical Laboratory Tests at 3 months
Number of subjects with abnormal vital signs
Vital signs, including height (only assessed at Screening), weight, systolic and diastolic blood pressure, heart rate, and body temperature, will be measured after the subject has been in a sitting position for 5 minutes.
Time frame: Change from Baseline vital signs at 3 months
Change from Screening "Questionnaire: Columbia Suicide Severity Rating Scale(C-SSRS)" at 90 days
C-SSRS will be assessed for the risk of suicide by an interview with the subject.
Time frame: Change from Baseline C-SSRS at 3 months
Change from Baseline "Questionnaire: Alzheimer's Disease Assessment Scale-Cognitive Subscale-13 task(ADAS-Cog-13)" at 90 days
ADAS-Cog-13 will be assessed for cognitive evaluation by interviews with the subject and caregiver/study partner.
Time frame: Change from Baseline ADAS-Cog-13 at 3 months
Change from Baseline "Questionnaire: Alzheimer's Disease Cooperative Study-Activities of Daily Living(ADCS-ADL)" at 90 days
ADCS-ADL will be assessed by caregiver/study partner interview regarding activities of daily living of the subject.
Time frame: Change from Baseline ADCS-ADL at 3 months
Change from Screening "Questionnaire: Mini-Mental State Examination(MMSE)" at 90 days.
MMSE will be assessed for the evaluation of cognitive function and severity of the disease by an interview with the subject.
Time frame: Change from Baseline MMSE at 3 months
Change from Screening "Questionnaire: Clinical Dementia Rating(CDR)" at 90 days.
CDR will be assessed for severity of the disease evaluation by interviews with the subject and caregiver/study partner.
Time frame: Change from Baseline CDR at 3 months
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