Actively Recruiting
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
Led by XyloCor Therapeutics, Inc. · Updated on 2025-08-03
106
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years at the time of consent
- Diagnosis of chronic angina from obstructive coronary artery disease not helped by drug therapy and unsuitable for bypass surgery or angioplasty
- Angina symptoms classified as Canadian Cardiovascular Society class II to IV
- Evidence of reversible left ventricular ischemia by stress tests or cardiac imaging that has not resolved
- Coronary angiography or CT angiography within past 18 months unless a newer test is needed
- Two baseline treadmill stress tests showing angina symptoms, following specific protocols
- Stable use of at least two classes of anti-anginal medications at maximum tolerated doses for at least 30 days before screening
- Approval by the eligibility review committee based on medical history and test results
- Agreement to use effective contraception for 6 months after the procedure if capable of reproduction
- Female participants must not donate eggs and male participants must not donate sperm for 6 months after treatment
- Ability to provide informed consent and complete study procedures
You will not qualify if you...
- Heart attack, stroke, or certain heart events within 60 days before screening
- Uncontrolled high cholesterol (LDL above 190 mg/dL) or high blood pressure despite treatment
- Untreated dangerous heart rhythm problems or very slow heart rate needing a new pacemaker
- Severe heart failure or very low heart pumping function
- Angina requiring opioid pain medications routinely
- Moderate to severe aortic valve narrowing or presence of a mechanical aortic valve
- Blood clot in the heart detected by ultrasound
- Body mass index over 45 kg/m2
- Low blood counts or abnormal liver or kidney function beyond set limits
- Poorly controlled diabetes or active serious diabetic eye disease
- Uncontrolled blood clotting disorders
- Unstable chronic lung disease despite treatment
- Active HIV, hepatitis B or C infections
- Severe immune system problems or recent cancer treatment within 5 years except certain skin cancers
- Allergy or contraindication to study medications, contrast agents, or anesthesia
- Pregnant or breastfeeding women
- Participation in another clinical trial or gene therapy recently
- Serious unstable medical or psychological conditions or drug abuse
- Known allergy to nickel
AI-Screening
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Trial Site Locations
Total: 1 location
1
Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
D
Dawn VP Clinical Operation, MSc.
CONTACT
B
Brenda Senior Director Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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