Heart FailureEarly Phase 1MERCURY-DCMNCT05837143
Myocardial Telomere Recapping Study for Dilated Cardiomyopathy
A Early Phase 1 study testing JV001 in people with Heart Failure and Dilated Cardiomyopathy, run by Shanghai East Hospital at 1 site in China.
Trial summary
The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated cardiomyopathic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Dilated Cardiomyopathy
- What is being tested?
- JV001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 30 Dec 2025
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCM≥1year;
- NYHA II-IV;
- LVEF ≤35%；
- Received maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months before enrollment with persistent heart failure; or unable to tolerate standardized pharmacotherapy recommended by guidelines (according to clinical data), but in which investigators assessed participants who could benefit from the study drug; or hospitalized for heart failure more than 2 times within 1 year and requiring intravenous diuretic therapy, while the condition is stable for more than 2 weeks;
- Have the ability to understand and voluntarily sign informed consent before the trial, and be able to complete the study in accordance with the requirements of the trial protocol;
- Male or female: (1) male subjects must agree to use contraception for at least 6 months after treatment visit; (2) the female subjects were not pregnant or breastfeeding; (3) Females of childbearing potential agree to comply with contraceptive guidance for at least 6 months after administration (see Appendix 1)
Who cannot join
- Patients with heart failure caused by heart diseases other than dilated cardiomyopathy (including but not limited to severe valvular heart disease, hyperthyroidism, congenital heart disease, acute viral myocarditis, acute coronary syndrome, hypertrophic obstructive cardiomyopathy, pericardial disease, myocardial amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or left ventricular aneurysm).
- Coronary angiography has a degree of narrowing of the left main coronary artery (LM), left anterior descending branch (LAD), left circumflex branch (LCX) or right coronary artery (RCA) > 50%.
- Uncontrolled arrhythmias that the investigator believes would affect this trial.
- Acute myocardial infarction within 6 months before screening
- Previous presence of subjects with immunological abnormalities that the investigators believe could affect this trial (including but not limited to congenital immunodeficiency, lupus erythematosus, primary vasculitis, systemic sclerosis, antiphospholipid syndrome, autoimmune liver disease, autoimmune thyroiditis).
- Those who have a history of tumor for less than 5 years or currently have a tumor, or those who have precancerous lesions confirmed by pathological examination (including but not limited to breast ductal carcinoma in situ, cervical dysplasia, etc.)
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- Known progress liver disease (active hepatitis A, chronic hepatitis B or C virus infection, non-cardiogenic cirrhosis, etc.)
- Acute infection developed within 2 weeks prior to screening requiring intravenous antibiotic therapy, or current infection requiring anti-infective therapy.
- Those who have a history of disseminated herpes simplex infection or recurrent (> 1 times) or disseminated herpes zoster.
- Percutaneous coronary intervention (PCI), coronary bypass grafting (CABG), Implantable Cardioverter Defibrillator (ICD)/permanent pacemaker/Cardiac resynchronisation therapy (CRT) implantation, radiofrequency ablation, ventricular volume reduction, valve repair or plasty, intra-aortic balloon counterpulsation, passive restraint devices (e.g., CorCap™ cardiac support devices), cardiac assist device implantation, heart transplantation, or other cardiac surgery may be received within 3 months prior to screening or within 3 months after administration.
- Those who donated ≥ 400 mL of blood within 4 weeks prior to screening, or who had significant blood loss equivalent to at least 400 mL, or who received blood transfusions within 8 weeks.
- Subjects with contraindications for coronary angiography
- Contraindications for Magnetic Resonance Imaging (MRI) detection, including but not limited to: pacemaker, defibrillator, artificial heart valve, metal clip after aneurysm surgery, drug perfusion device implanted in the body, any electronic device implanted in the body (neurostimulator, bone growth stimulator), intravascular embolization steel ring, filter, ECG recording monitor, shrapnel or iron sand in the body, fixed steel plate and nails after fracture surgery, cochlear implant, intraocular metal foreign body, etc.; Claustrophobia, etc.
- Those who have a history of substance abuse within the past five years or have used drugs in the 3 months prior to the test.
- Are participating in other clinical trials, or have been completed less than 3 months after the end of other clinical trials.
- Abnormal liver function: ALT or AST > 3 times the upper limit of normal value (ULN).
- Abnormal renal function: glomerular filtration rate < 30 mL/min or dialysis-dependent.
- Hematologic disorders: thrombocytopenia is defined as <50,000 platelets/μL within 30 days prior to screening; Anaemia is defined as haemoglobin <10 g/dL within 30 days prior to screening or dependence on blood transfusion; Neutropenia is defined as an absolute neutrophil value < 1500 mm^3 within 30 days prior to screening.
- Acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive, or previously diagnosed immunodeficiency with an absolute neutrophil count < 1000 cells/mm^3.
- Those who are positive for treponema pallidum antibodies and positive for rapid plasma reagin test (RPR).
- AAV9 neutralizing antibody titer > 1:50
- Subjects with a history of active tuberculosis or active or inactive TB infection at screening.
- 4 weeks prior to screening, or those who plan to receive a live (attenuated) vaccine during the trial.
- Those who smoked more than 20 cigarettes per day or habitually used nicotine-containing products in the 3 months prior to screening, drank more than 14 units of alcohol per week (1 unit of alcohol = 360mL of beer or 45mL of spirits or 150mL of wine with 40% alcohol content) or took alcohol-containing products 2 days before administration.
- The investigators believe that there are other conditions that would have an impact on intolerance to this treatment or endpoint evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study of JV001 in the Treatment of Patients With Heart Failure Due to Dilated Cardiomyopathy (Telomere Recapping to Restore Mitochondrial Biogenesis Study for Dilated Cardiomyopathy)
The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated cardiomyopathic patients.
Read the detailed description
It is an open-label, 6+6 design study involving two dosages ( 2×10^11vg/kg, and 6×10^11vg/kg) aimed to explore the safety, pharmacokinetics, immunology, and preliminary efficacy of JV001.
- Conditions
- Heart Failure, Dilated Cardiomyopathy
- Being tested
- JV001
- Keywords
- Adeno-associated virus, modTERT, Dilated Cardiomyopathy
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JV001Biological
JV001 (AAV9/modTERT) will be delivered by a percutaneous method in the catheter laboratory. Dose: 2×10^11vg/kg，or 6×10^11vg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: JV001 | Experimental | Subjects will receive a single intracoronary infusion of JV001 at a dose of 2×10^11vg/kg, and 6×10^11vg/kg. Receives: Biological: JV001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) within 28 days of a single intracoronary infusion of JV001
To evaluate the DLT occurred within 28 days after JV001 infusion
Measured: 28 days
Incidence of adverse events and serious adverse events within 1 year of administration
To evaluate the safety of JV001 treatment
Measured: 1 year
Secondary outcomes (8)
Left ventricular ejection fraction
Changes in left ventricular ejection fraction (LVEF as percentage) as assessed by echocardiography
Measured: Baseline, Week 12, Week 26, Week 52
Myocardial remodeling assessed by Cardiac Magnetic Resonance (CMR) Imaging
Changes in left ventricular mass (absolute (ml) and index (ml/m2). Changes in left ventricular diastolic volume (ml). Changes in right ventricular diastolic volume (ml). Changes in left ventricular stroke volume
Measured: Baseline, Week 26
Change in N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) from baseline to Week 2, 4, 12, 26, 52
To evaluate the changes in NT-proBNP of subjects at 2, 4, 12, 26, and 52 weeks after medication from baseline. NT-proBNP is a biomarker for heart failure with a higher level indicating increased mortality and cardiovascular hospitalization in patients with heart failure.
Measured: Baseline, Week 2, Week 4, Week 12, Week 26, Week 52
Change in 6-minute Walk Test (6MWT) from baseline to Week 12，26，52
The 6MWT measures the distance walked in meters during a 6-minute test. Lower scores compared to baseline indicate worsening in function, and higher scores compared to baseline indicate improvement in function.
Measured: Baseline, Week 12, Week 26, Week 52
Change in total immunoglobulin and neutralizing antibodies from baseline to Week 2, Week 4, Week 12, Week 26, Week 52
Evaluate the changes in the formation of Anti-AAV9 antibodies.
Measured: Baseline, Week 2, Week 4, Week 12, Week 26, Week 52
Change in vector DNA levels in subjects' biological samples from baseline to Day 1, Day2, Day7, Week 2, Week 4, Week 12, Week 26, Week 52
To evaluate the changes of AAV viral load in subjects' biological samples from baseline
Measured: Baseline, Day 1, Day2, Day7, Week 2, Week 4, Week 12, Week 26, Week 52
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score from baseline to Week 12，26，52
The MLHFQ is a patient-report questionnaire used to assess the quality of life of heart failure patients. Higher scores indicate a lower quality of life.
Measured: Baseline, Week 12, Week 26, Week 52
Change of New York Heart Association (NYHA) functional classification from baseline to Week 12，26，52
The NYHA functional classification is the most commonly used classification system for patients with heart failure. Changes from baseline to a higher class indicate a worsening in symptoms.
Measured: Baseline, Week 12, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start30 Mar 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Juvensis Therapeutics Biotechnology Company Limited
- Responsible party
- Principal investigator, Wei Han, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837143
- Sponsor's protocol ID
- JV001-02
- Acronym
- MERCURY-DCM
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schultheiss HP, Fairweather D, Caforio ALP, Escher F, Hershberger RE, Lipshultz SE, Liu PP, Matsumori A, Mazzanti A, McMurray J, Priori SG. Dilated cardiomyopathy. Nat Rev Dis Primers. 2019 May 9;5(1):32. doi: 10.1038/s41572-019-0084-1.
PubMed 31073128Chang ACY, Chang ACH, Kirillova A, Sasagawa K, Su W, Weber G, Lin J, Termglinchan V, Karakikes I, Seeger T, Dainis AM, Hinson JT, Seidman J, Seidman CE, Day JW, Ashley E, Wu JC, Blau HM. Telomere shortening is a hallmark of genetic cardiomyopathies. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9276-9281. doi: 10.1073/pnas.1714538115. Epub 2018 Aug 27.
PubMed 30150400Sahin E, Colla S, Liesa M, Moslehi J, Muller FL, Guo M, Cooper M, Kotton D, Fabian AJ, Walkey C, Maser RS, Tonon G, Foerster F, Xiong R, Wang YA, Shukla SA, Jaskelioff M, Martin ES, Heffernan TP, Protopopov A, Ivanova E, Mahoney JE, Kost-Alimova M, Perry SR, Bronson R, Liao R, Mulligan R, Shirihai OS, Chin L, DePinho RA. Telomere dysfunction induces metabolic and mitochondrial compromise. Nature. 2011 Feb 17;470(7334):359-65. doi: 10.1038/nature09787. Epub 2011 Feb 9.
PubMed 21307849Wang D, Tai PWL, Gao G. Adeno-associated virus vector as a platform for gene therapy delivery. Nat Rev Drug Discov. 2019 May;18(5):358-378. doi: 10.1038/s41573-019-0012-9.
PubMed 30710128
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of JV001 in the Treatment of Patients With Heart Failure Due to Dilated Cardiomyopathy (Telomere Recapping to Restore Mitochondrial Biogenesis Study for Dilated Cardiomyopathy)
- ClinicalTrials.gov ID
- NCT05837143
- Acronym / sponsor ID
- MERCURY-DCM / JV001-02
- Conditions
- Heart Failure, Dilated Cardiomyopathy
- Keywords
- Adeno-associated virus, modTERT, Dilated Cardiomyopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai Juvensis Therapeutics Biotechnology Company Limited
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 May 2023 (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 aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated cardiomyopathic patients.
Detailed description
It is an open-label, 6+6 design study involving two dosages ( 2×10^11vg/kg, and 6×10^11vg/kg) aimed to explore the safety, pharmacokinetics, immunology, and preliminary efficacy of JV001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: JV001 | Experimental | Biological: JV001Subjects will receive a single intracoronary infusion of JV001 at a dose of 2×10^11vg/kg, and 6×10^11vg/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DCM≥1year;
- NYHA II-IV;
- LVEF ≤35%；
- Received maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months before enrollment with persistent heart failure; or unable to tolerate standardized pharmacotherapy recommended by guidelines (according to clinical data), but in which investigators assessed participants who could benefit from the study drug; or hospitalized for heart failure more than 2 times within 1 year and requiring intravenous diuretic therapy, while the condition is stable for more than 2 weeks;
- Have the ability to understand and voluntarily sign informed consent before the trial, and be able to complete the study in accordance with the requirements of the trial protocol;
Key exclusion criteria (25 listed)
- Patients with heart failure caused by heart diseases other than dilated cardiomyopathy (including but not limited to severe valvular heart disease, hyperthyroidism, congenital heart disease, acute viral myocarditis, acute coronary syndrome, hypertrophic obstructive cardiomyopathy, pericardial disease, myocardial amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or left ventricular aneurysm).
- Coronary angiography has a degree of narrowing of the left main coronary artery (LM), left anterior descending branch (LAD), left circumflex branch (LCX) or right coronary artery (RCA) > 50%.
- Uncontrolled arrhythmias that the investigator believes would affect this trial.
- Acute myocardial infarction within 6 months before screening
- Previous presence of subjects with immunological abnormalities that the investigators believe could affect this trial (including but not limited to congenital immunodeficiency, lupus erythematosus, primary vasculitis, systemic sclerosis, antiphospholipid syndrome, autoimmune liver disease, autoimmune thyroiditis).
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 |
|---|---|---|
| JV001JV001 (AAV9/modTERT) will be delivered by a percutaneous method in the catheter laboratory. Dose: 2×10^11vg/kg，or 6×10^11vg/kg. | Biological | Active Comparator: JV001 |
Primary outcome
Dose-limiting toxicity (DLT) within 28 days of a single intracoronary infusion of JV001
Time frame: 28 days
To evaluate the DLT occurred within 28 days after JV001 infusion
Incidence of adverse events and serious adverse events within 1 year of administration
Time frame: 1 year
To evaluate the safety of JV001 treatment
8 secondary outcomes
Left ventricular ejection fraction
Time frame: Baseline, Week 12, Week 26, Week 52
Myocardial remodeling assessed by Cardiac Magnetic Resonance (CMR) Imaging
Time frame: Baseline, Week 26
Change in N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) from baseline to Week 2, 4, 12, 26, 52
Time frame: Baseline, Week 2, Week 4, Week 12, Week 26, Week 52
Change in 6-minute Walk Test (6MWT) from baseline to Week 12，26，52
Time frame: Baseline, Week 12, Week 26, Week 52
Change in total immunoglobulin and neutralizing antibodies from baseline to Week 2, Week 4, Week 12, Week 26, Week 52
Time frame: Baseline, Week 2, Week 4, Week 12, Week 26, Week 52
Change in vector DNA levels in subjects' biological samples from baseline to Day 1, Day2, Day7, Week 2, Week 4, Week 12, Week 26, Week 52
Time frame: Baseline, Day 1, Day2, Day7, Week 2, Week 4, Week 12, Week 26, Week 52
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score from baseline to Week 12，26，52
Time frame: Baseline, Week 12, Week 26, Week 52
Change of New York Heart Association (NYHA) functional classification from baseline to Week 12，26，52
Time frame: Baseline, Week 12, Week 26, Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 31073128Schultheiss HP, Fairweather D, Caforio ALP, Escher F, Hershberger RE, Lipshultz SE, Liu PP, Matsumori A, Mazzanti A, McMurray J, Priori SG. Dilated cardiomyopathy. Nat Rev Dis Primers. 2019 May 9;5(1):32. doi: 10.1038/s41572-019-0084-1.
- Background: PubMed 30150400Chang ACY, Chang ACH, Kirillova A, Sasagawa K, Su W, Weber G, Lin J, Termglinchan V, Karakikes I, Seeger T, Dainis AM, Hinson JT, Seidman J, Seidman CE, Day JW, Ashley E, Wu JC, Blau HM. Telomere shortening is a hallmark of genetic cardiomyopathies. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9276-9281. doi: 10.1073/pnas.1714538115. Epub 2018 Aug 27.
- Background: PubMed 21307849Sahin E, Colla S, Liesa M, Moslehi J, Muller FL, Guo M, Cooper M, Kotton D, Fabian AJ, Walkey C, Maser RS, Tonon G, Foerster F, Xiong R, Wang YA, Shukla SA, Jaskelioff M, Martin ES, Heffernan TP, Protopopov A, Ivanova E, Mahoney JE, Kost-Alimova M, Perry SR, Bronson R, Liao R, Mulligan R, Shirihai OS, Chin L, DePinho RA. Telomere dysfunction induces metabolic and mitochondrial compromise. Nature. 2011 Feb 17;470(7334):359-65. doi: 10.1038/nature09787. Epub 2011 Feb 9.
- Background: PubMed 30710128Wang D, Tai PWL, Gao G. Adeno-associated virus vector as a platform for gene therapy delivery. Nat Rev Drug Discov. 2019 May;18(5):358-378. doi: 10.1038/s41573-019-0012-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JV001 in people with Heart Failure and Dilated Cardiomyopathy, run by Shanghai East Hospital at 1 site in China.
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 6 inclusion and 25 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 16 Jul 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) within 28 days of a single intracoronary infusion of JV001 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837143, which also lists 4 linked publications.
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 16 Jul 2024.