NAN-101 in Patients With Class III Heart Failure — NAN-CS101  

Heart Failure Clinical Trial

Official title: Phase 1 Open Label, Dose Escalation Trial of Intracoronary Infusion of NAN-101 in Subjects With NYHA Class III Heart Failure

Status Recruiting

Clinical Trial Summary

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Clinical Trial Description

The primary endpoint for this study is safety as measured by the following which will be assessed over the 12 month follow-up period as indicated in the Data Collection Table:

• Adverse Events

• All-cause Mortality

• Heart failure (HF) Hospitalization

Secondary Endpoints

The secondary safety endpoints assessed will include the following:

• Echocardiographic assessments at 4 weeks +/- 3 days post-administration of BNP116.sc-CMV.I1c including

• Echocardiographic assessments of LVEF, LVEVD, LVEDVI, VLESV, LVEVI, SpI and GLSand degree of mitral regurgitation o

The secondary efficacy endpoints will explore efficacy. Functional endpoints will be assessed as changes from baseline to 6 and 12 months following investigational product administration as indicated. These endpoints include:

Functional Status & Hospitalizations

• Peak VO2 assessed by cardiopulmonary exercise testing

• 6-minute walk test

• New York Heart Association (NYHA) Classification

• Total number of days alive out-of-hospital (as well as total days out-of-hospital as a % of total days alive post study intervention)

Physiologic Assessments at 6 and 12 months compared to baseline

• Echocardiographic assessments of LVEF, LVEVD, LVEDVI, VLESV, LVEVI, SpI and GLSand degree of mitral regurgitation

• NT-proBNP level

Quality of Life at 6 and 12 months compared to baseline

o Health related quality of life as assessed by Minnesota Living with Heart Failure Questionnaire (MLWHFQ)

The following endpoints will also be measured over the 12 month follow-up period and long-term follow-up period (until month 36 post-intervention):

• Survival

• Cardiac transplantation

• Left ventricular assist device (LVAD) implantation ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiovascular Diseases
• Congestive Heart Failure
• Heart Arrhythmia
• Heart Disease, Ischemic
• Heart Diseases
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Failure,Congestive
• Heart; Complications
• Myocardial Ischemia

• NCT number: NCT04179643
• Study type: Interventional
• Source: Asklepios Biopharmaceutical, Inc.
• Contact: AskBio Medical Affairs
• Phone: 9195616210
• Email: askfirst@askbio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: November 20, 2019
• Completion date: December 31, 2026