Phase 2b Study of XC001 Gene Therapy Delivered by Heart Catheter for Adults With Chronic Refractory Angina and Coronary Artery Disease

What this Trial Is About

Researchers are investigating the safety and effectiveness of XC001 gene therapy delivered through a cardiac catheter in adults with refractory angina due to obstructive coronary artery disease CAD. The study aims to evaluate this treatment option for patients who have limited therapeutic choices and persistent angina symptoms despite standard care. This phase 2b trial includes an initial safety phase followed by a randomized, double-blind comparison with a sham procedure. The study consists of two parts. Part 1 enrolls three patients who receive the XC001 gene therapy via a catheter into the heart muscle to assess safety and feasibility. After safety review, Part 2 will randomize about 106 patients to receive either XC001 gene therapy or a sham catheterization procedure without injection. The treatment is delivered using the Extroducer Infusion Catheter System, while the sham group undergoes a similar catheter procedure without the actual gene delivery. Participants will attend screening and safety monitoring visits for up to 12 months after treatment. Assessments include stress tests, imaging, and clinical evaluations to measure heart function and angina symptoms. Researchers will focus on a composite endpoint at 6 months to evaluate treatment effects. Safety data from all participants will be reviewed throughout the study. The total participation time, including follow-up, may extend beyond 26 weeks with an optional extension period.

Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.