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

Conditions

• Coronary Artery Disease
• Refractory Angina

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• XC001 — COMBINATION_PRODUCT
  XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System.
• Sham (No Treatment) — COMBINATION_PRODUCT
  Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections

Study Details

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 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.

Key Dates

First listed

Jul 2, 2025

Start date

Jul 8, 2025

Status verified

Sep 2026

Primary completion

Jun 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

106 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Treatment group
  Those randomized to the treatment group will have XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System (delivery catheter).
• Sham Comparator: Sham group
  Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections

Primary Outcome Measure

Composite endpoint [ Time Frame: 6 months ]

Central Contacts

• Dawn Byrnes VP Clinical Operation, MSc.
  888-290-0081
  [email protected]
• Brenda Garrison, Senior Director Clinical Operations
  888-290-0081
  [email protected]

Locations (14)

Find similar trials in Birmingham, AL

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