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

NCT05016427 | Unknown Phase 1

• 1 other identifier: GB301-A01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• All 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.

  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.

  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.

  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

  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.

  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.

  Change from Baseline C-SSRS at 3 months

Secondary Outcomes (4)

• Change from Baseline "Questionnaire: Alzheimer's Disease Assessment Scale-Cognitive Subscale-13 task(ADAS-Cog-13)" at 90 days

  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

  Change from Baseline ADCS-ADL at 3 months

• Change from Screening "Questionnaire: Mini-Mental State Examination(MMSE)" at 90 days.

  Change from Baseline MMSE at 3 months

• Change from Screening "Questionnaire: Clinical Dementia Rating(CDR)" at 90 days.

  Change from Baseline CDR at 3 months

Study Arms (2)

VT301(low dose)

EXPERIMENTAL

VT301 low dose: 8.5x10\^4 cells/kg

Biological: VT301

VT301(high dose)

EXPERIMENTAL

VT301 high dose: 1.7x10\^5 cells/kg

Biological: VT301

Interventions

VT301 BIOLOGICAL

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.

VT301(high dose); VT301(low dose)

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 79≥ aged ≥50 years at the time of signing Informed Consent Form.
• Patients (or their legally acceptable representative) can understand and provide informed consent to participate in the study.
• Diagnosis of mild-to-moderate AD according to National Institute of Aging and Alzheimer Association (NIA-AA) diagnostic guidelines.
• Mild-to-moderate AD with MMSE ≥ 10 points and CDR Global Score (CDR-GS) of 0.5 to 2.0 points at Screening.
• Have ≥1 identified adult caregiver (study partner) who is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥8 hours/week; and agrees to accompany the subject to each study visit and participate in clinical assessments.

You may not qualify if:

• A medical history of any of the following:
• Stroke, transient ischemic attack (TIA), or unexpected loss of consciousness within one year at Screening.
• Clinically significant cerebral hemorrhage, bleeding lesion, or cerebrovascular abnormality.
• Malignant tumor within 5 years at Screening (no time limit for stable non-metastatic prostate cancer or completely resected non-melanoma skin cancer of 6 months or longer).
• Unable to perform MRI tests by enthesis/transplantation of metallic substances (metallic bone fixings, heart devices, etc.) in the body.
• Allergic or hypersensitive to the treatment of regulatory T cell components.
• Patients who have any of the following accompanying diseases/symptoms:
• Medical conditions or neurological/neural degenerative disease (excluding AD) considered to cause cognitive impairment or to affect the evaluation of clinical trials (discontinuation, nonconformity, interference, etc.) in the judgment of the investigator.
• History of clinically significant gastrointestinal, endocrine, inflammatory or cardiovascular disease that is not controlled by drug/non-drug treatment.
• History of mental illness (e.g., schizophrenia, major depression disorder, bipolar disorder, delirium, etc.) that is considered to affect participation in clinical trials under the judgment of the investigator.
• History of alcohol or drug abuse or dependence (except caffeine or nicotine).
• Vision, hearing, or mobility (behavior) has deteriorated to a degree that interferes with or is unable to perform clinical trial procedures.
• Hypersensitive to bee venom.
• High blood pressure who are not controlled by drug/non-drug treatment (SBP \> 165 mmHg or DBP \> 96 mmHg).
• Hypersensitive to gentamycin.

Sponsors & Collaborators

• VTBIO Co. LTD: lead

Study Sites (1)

Vtbio Co., Ltd

Seoul, South Korea

RECRUITING

Related Publications (1)

• Yang H, Byun MS, Ha NY, Yang J, Park SY, Park JE, Yi D, Chang YT, Jung WS, Kim JY, Kim J, Lee DY, Bae H. A preclinical and phase I clinical study of ex vivo-expanded amyloid beta-specific human regulatory T cells in Alzheimer's disease. Biomed Pharmacother. 2024 Dec;181:117721. doi: 10.1016/j.biopha.2024.117721. Epub 2024 Dec 2.

  PMID: 39626378 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 23, 2021
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: April 1, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)