Alzheimer DiseasePhase 1/2NCT03865017
A Safety and Tolerability Study of GB301
A Phase 1/2 study testing Regulatory T cells and Saline in people with Alzheimer Disease, run by VTBIO Co. LTD at 1 site in Australia.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions at a single dose strength of GB301 in subjects with mild to moderate AD. Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Regulatory T cells and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2019to 1 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have voluntarily agreed to participate in the study and have signed a human research ethics committee-approved consent form after being briefed on the clinical study before undergoing any study-related procedure.
- Male or female subjects aged ≥40 to ≤72 years with mild to moderate AD with an MMSE score at Screening and Baseline of ≥11.
- Diagnostic confirmation by positron-emission tomography (PET) with florbetaben or another approved amyloid PET ligand. A previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during the Screening Period.
- Subjects who have been clinically diagnosed with mild-to-moderate AD according to the 2011 version of the National Institute on Aging and Alzheimer's Association criteria and ≥6 month decline in cognitive function.
- Subjects must have a caregiver/study partner who, in the opinion of the site principal investigator, has contact with the study subject for a sufficient amount of time (i.e. at least 6 hours per week) to provide informative responses on protocol assessments, and is willing and able to participate in all clinic visits. The legally acceptable representative (if appointed) and caregiver/study partner must provide written informed consent to participate in the study.
- Formal education of ≥8 years.
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- Modified Hachinski Ischaemic Score ≤4 at Screening Visit.
- The subject has had a documented computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association diagnostic criteria for probable AD. The scan must not show evidence for an alternative etiology for dementia.
- No active depression and a Geriatric Depression Scale (15 items) score of ≤5.
- Subjects should be generally healthy with mobility (ambulatory or ambulatory aided, i.e. walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
- Subject, if female, is postmenopausal (last natural menses ≥24 months) or has undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses is <24 months, a serum follicle-stimulating hormone (FSH) value confirming post menopausal status should be employed, except if documentation of bilateral tubal ligation or hysterectomy is available.
- Women of childbearing potential need to apply at least 1 highly efficient contraceptive method.
- Male subject either agrees to use a highly efficient method of contraception if his female partner is of childbearing potential or must have been surgically sterilized prior to the Screening Visit.
- Highly efficient methods of contraception are defined as:
- Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle before IP administration.
- Total abstinence from sexual intercourse between the Screening Visit and 4 weeks after the last IP administration.
- Intrauterine device.
- Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies, or cream).
- Subjects with the capability of performing all cognitive and other tests required for this study in the opinion of the investigator.
Who cannot join
- Subjects who have taken drugs known to have or carry the potential for significant interactions with the IP within 14 days prior to the administration of this IP and during the study (e.g. non-specific immunosuppressive drugs, specific T cell immunosuppressive drugs, immunostimulants, immunomodulating agents) or any drugs that are considered unsuitable by investigator's judgment.
- Subjects who have donated blood within 30 days prior to Screening or who have participated in clinical studies of other investigational medicinal products or commercially available drugs within 60 days prior to Screening.
- Subjects who have experienced significant AEs or hypersensitivity to previous Treg therapy.
- Subjects whom the investigator finds unsuitable for the clinical study participation based on clinically significant laboratory results, vital signs, ECG, or other examinations.
- Subjects with a history of mental illness that may interfere with their participation in the clinical study, such as schizophrenia or bipolar affective disorder according to the investigator's judgment.
- Subjects with any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the investigator, might be a contributing cause to the subject's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns.
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- Subjects who have had a stroke or transient ischemic attack or unexplained loss of consciousness in the past 1 year.
- Subjects who have a history of clinically relevant brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities.
- Subjects with clinically relevant gastrointestinal, endocrine, inflammatory, or cardiovascular diseases that are not controlled by diet or medication.
- Subjects with a history of alcohol or other substance abuse or dependence (with the exception of caffeine and nicotine) or a positive drug screen at Screening (amphetamines, barbiturates, cocaine, methamphetamine, methadone, opiates, phencyclidine, and tetrahydrocannabinol).
- Subject has serum hepatitis, is a carrier of the hepatitis B virus surface antigen, is a carrier of the hepatitis C antibody, or is seropositive for human immunodeficiency virus antibodies as confirmed at Screening.
- Subject has a history of cancer within 3 years of Screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for ≥6 months.
- Subjects with uncontrolled hypertension with a resting systolic blood pressure exceeding 165 mmHg or diastolic blood pressure exceeding 96 mmHg.
- Subjects with severe renal impairment (serum creatinine ≥1.7 mg/dL) at Screening.
- Subjects with clinically relevant hepatic impairment (any of levels of alanine transaminase, aspartate transaminase, or bilirubin ≥2.0 times the upper limit of normal) at Screening.
- Subjects who are taking or are expected to take a prohibited concomitant medication, such as steroid drugs and supplements that improve the blood circulation (e.g. omega-3 fatty acids) during the study. Concomitant medication affecting the central nervous system should be stable for ≥1 month before Screening and should not change during the study. Standard AD medication is permitted if initiated ≥3 months before enrollment and on a stable dose for ≥2 months.
- Subjects who are unsuitable for participating in this clinical study for any other reason, based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Bht Lifescience Australia Pty Ltd
Brisbane, Queensland, 4000
Michael Woodward, Prof.
About this study
Official title: A Safety and Tolerability Study of GB301 Given as a Single Intravenous Dose in Subjects With Mild to Moderate Alzheimer's Disease
The primary objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions at a single dose strength of GB301 in subjects with mild to moderate AD.
- Conditions
- Alzheimer Disease
- Being tested
- Regulatory T cells, Saline
- Keywords
- Regulatory T cell, Treg, cell therapy, autologous
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulatory T cellsBiological
Also called GB301
The trial will be carried out in Alzheimer's disease patients. The investigators will isolate CD4+CD25+ Tregs from these patients, expand and injection.
SalineOther
Also called Placebo
Saline+cell suspension solution infusion
| Study group | Role | What they receive |
|---|---|---|
| Regulatory T cells | Experimental | Biologicals: Autologous Regulatory T cells (1.7*10^5 cells/kg, i.v) other name: GB301 Receives: Biological: Regulatory T cells |
| Placebo | Placebo comparator | Saline+cell suspension solution infusion Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal clinical chemistry parameters
Blood samples will be collected for the assessment of following clinical chemistry parameters: Albumin, Total bilirubin, Total protein, Calcium, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Creatinine, Glucose, Sodium, Potassium, Chloride, Bicarbonate, LDH, FSH, Uricacid
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal Hematology parameters
Blood samples will be collected for the assessment of following hematology parameters: red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Platelet, white blood cell (WBC) count, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal Coagulation parameters
Blood samples will be collected for the assessment of following coagulation parameters: Prothrombin Time(PT), International normalized ratio(INR), partial thromboplastin time (PTT)
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal Urinalysis parameters
Samples will be collected to measure specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones.
Measured: Between Baseline and 12 weeks
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.
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal vital signs
Vital signs, including height (㎡, only assessed at Screening), weight(kg), systolic and diastolic blood pressure(mm Hg), heart rate(bpm), and body temperature(℃), will be measured after the subject has been in a sitting position for 5 minutes.
Measured: Between Baseline and 12 weeks
Number of subjects with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Between Baseline and 12 weeks
Number of subjects with abnormal physical examination
A full physical examination will include assessments of the general apperance, skin, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, abdomen, extremities, musculoskeletal, neurological, lymph nodes etc.
Measured: Between Baseline and 12 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events.
Measured: Between Baseline and 12 weeks
Secondary outcomes (2)
Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score
13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.
Measured: baseline, 29, 57, and 85 days
Change from baseline in MMSE score
The MMSE is a brief, screening instrument often used in clinical studies to assess dementia severity. The MMSE assesses several aspects of memory and cognitive functioning including orientation, attention, concentration, comprehension, recall, and praxis. The total possible score is 30, with high scores indicating less impairment.
Measured: baseline, 29, 57, and 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VTBIO Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BHT Lifescience Austrailia Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Jaeyoon Kim, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865017
- Sponsor's protocol ID
- GB301-A01
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Tolerability Study of GB301 Given as a Single Intravenous Dose in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03865017
- Acronym / sponsor ID
- GB301-A01
- Conditions
- Alzheimer Disease
- Keywords
- Regulatory T cell, Treg, cell therapy, autologous
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VTBIO Co. LTDIndustry (pharma, biotech, devices)
- Collaborators
- BHT Lifescience Austrailia Pty Ltd.
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions at a single dose strength of GB301 in subjects with mild to moderate AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regulatory T cells | Experimental | Biological: Regulatory T cellsBiologicals: Autologous Regulatory T cells (1.7*10^5 cells/kg, i.v) other name: GB301 |
| Placebo | Placebo comparator | Other: SalineSaline+cell suspension solution infusion |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects who have voluntarily agreed to participate in the study and have signed a human research ethics committee-approved consent form after being briefed on the clinical study before undergoing any study-related procedure.
- Male or female subjects aged ≥40 to ≤72 years with mild to moderate AD with an MMSE score at Screening and Baseline of ≥11.
- Diagnostic confirmation by positron-emission tomography (PET) with florbetaben or another approved amyloid PET ligand. A previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during the Screening Period.
- Subjects who have been clinically diagnosed with mild-to-moderate AD according to the 2011 version of the National Institute on Aging and Alzheimer's Association criteria and ≥6 month decline in cognitive function.
- Subjects must have a caregiver/study partner who, in the opinion of the site principal investigator, has contact with the study subject for a sufficient amount of time (i.e. at least 6 hours per week) to provide informative responses on protocol assessments, and is willing and able to participate in all clinic visits. The legally acceptable representative (if appointed) and caregiver/study partner must provide written informed consent to participate in the study.
Key exclusion criteria (17 listed)
- Subjects who have taken drugs known to have or carry the potential for significant interactions with the IP within 14 days prior to the administration of this IP and during the study (e.g. non-specific immunosuppressive drugs, specific T cell immunosuppressive drugs, immunostimulants, immunomodulating agents) or any drugs that are considered unsuitable by investigator's judgment.
- Subjects who have donated blood within 30 days prior to Screening or who have participated in clinical studies of other investigational medicinal products or commercially available drugs within 60 days prior to Screening.
- Subjects who have experienced significant AEs or hypersensitivity to previous Treg therapy.
- Subjects whom the investigator finds unsuitable for the clinical study participation based on clinically significant laboratory results, vital signs, ECG, or other examinations.
- Subjects with a history of mental illness that may interfere with their participation in the clinical study, such as schizophrenia or bipolar affective disorder according to the investigator's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regulatory T cellsAlso: GB301The trial will be carried out in Alzheimer's disease patients. The investigators will isolate CD4+CD25+ Tregs from these patients, expand and injection. | Biological | Regulatory T cells |
| SalineAlso: PlaceboSaline+cell suspension solution infusion | Other | Placebo |
Primary outcome
Number of subjects With Clinically Significant Abnormalities in 12-lead Electrocardiogram
Time frame: Between Baseline and 12 weeks
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.
Number of subjects with abnormal clinical chemistry parameters
Time frame: Between Baseline and 12 weeks
Blood samples will be collected for the assessment of following clinical chemistry parameters: Albumin, Total bilirubin, Total protein, Calcium, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Creatinine, Glucose, Sodium, Potassium, Chloride, Bicarbonate, LDH, FSH, Uricacid
Number of subjects with abnormal Hematology parameters
Time frame: Between Baseline and 12 weeks
Blood samples will be collected for the assessment of following hematology parameters: red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Platelet, white blood cell (WBC) count, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil
Number of subjects with abnormal Coagulation parameters
Time frame: Between Baseline and 12 weeks
Blood samples will be collected for the assessment of following coagulation parameters: Prothrombin Time(PT), International normalized ratio(INR), partial thromboplastin time (PTT)
Number of subjects with abnormal Urinalysis parameters
Time frame: Between Baseline and 12 weeks
Samples will be collected to measure specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones.
Number of subjects with abnormal vital signs
Time frame: Between Baseline and 12 weeks
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.
Number of subjects with abnormal vital signs
Time frame: Between Baseline and 12 weeks
Vital signs, including height (㎡, only assessed at Screening), weight(kg), systolic and diastolic blood pressure(mm Hg), heart rate(bpm), and body temperature(℃), will be measured after the subject has been in a sitting position for 5 minutes.
Number of subjects with adverse events (AEs)
Time frame: Between Baseline and 12 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of subjects with abnormal physical examination
Time frame: Between Baseline and 12 weeks
A full physical examination will include assessments of the general apperance, skin, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, abdomen, extremities, musculoskeletal, neurological, lymph nodes etc.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Between Baseline and 12 weeks
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events.
2 secondary outcomes
Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score
Time frame: baseline, 29, 57, and 85 days
Change from baseline in MMSE score
Time frame: baseline, 29, 57, and 85 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaeyoon Kim study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regulatory T cells and Saline in people with Alzheimer Disease, run by VTBIO Co. LTD at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaeyoon Kim (+82-2-553-9777, jykim@gmp.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects With Clinically Significant Abnormalities in 12-lead Electrocardiogram (time frame: Between Baseline and 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.