Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Part 1 of the study is
| Condition(s) | Refractory Angina, Coronary Artery Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study. Part 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×101 |
| Who can participate | Inclusion Criteria: 1. Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF. 2. Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined by ESC Joint Study Group on the Treatment of Refractory Angina Refractory, Mannheimer et al, EHJ 2002 and the 2013 ESC guidelines on the management of stable coronary artery disease, Montalescot et al, EHJ 2013; and Jolicoeur et al 2008). 3. Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris. 4. History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- p |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | XyloCor Therapeutics, Inc. |
| Locations | Cincinnati, Ohio, United States |
| Start date | 2025-06-24 |
| NCT ID | NCT07048808 |
| Official listing | https://clinicaltrials.gov/study/NCT07048808 |