Actively Recruiting
Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (With 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety
Led by XyloCor Therapeutics, Inc. · Updated on 2025-08-03
106
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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...
- Males and females aged 18 to 85 years at the time of consent
- Diagnosis of chronic angina due to obstructive coronary artery disease, refractory to drug therapy and unsuitable for revascularization
- Angina classified as CCS Functional Class II to IV
- Evidence of reversible left ventricular ischemia confirmed by stress tests or imaging
- Coronary angiography or CT angiography within the past 18 months unless clinically indicated otherwise
- Two baseline treadmill stress tests meeting specific criteria for angina-induced limitation
- Stable regimen of at least two anti-anginal medication classes at maximally tolerated doses for 30 days prior to screening
- Approved by the Eligibility Review Committee to undergo study procedures
- Agreement to use effective contraception for 6 months post-procedure if capable of procreation
- Agreement not to donate sperm or oocytes for 6 months following study treatment
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Myocardial infarction or stroke within 60 days prior to screening
- Uncontrolled high cholesterol (LDL >190 mg/dL) or hypertension (systolic >180 mmHg, diastolic >100 mmHg)
- Untreated malignant ventricular arrhythmias or bradyarrhythmias requiring new pacemaker
- Severe heart failure (NYHA Class III or IV) or left ventricular ejection fraction below 25%
- Angina episodes requiring routine opiate use
- Moderate to severe aortic valve stenosis or mechanical aortic valve
- Presence of ventricular thrombus unless resolved after treatment
- Body mass index over 45 kg/m2
- Significant blood count or liver function abnormalities
- Diabetes with HbA1c over 9.5% or active proliferative diabetic retinopathy
- Uncontrolled coagulation disorders or unstable chronic obstructive pulmonary disease
- HIV, active hepatitis B or C infection, or severe immunocompromise
- Recent cancer diagnosis or treatment within 5 years except certain skin cancers
- Allergies or contraindications to study-related contrast agents or anesthesia
- Pregnancy or breastfeeding
- Participation in another investigational trial within 30 days or 5 half-lives of the drug
- Prior gene therapy participation unless previously randomized to placebo
- Serious unstable medical or psychological conditions or drug-seeking behavior
- Known allergy to nickel used in catheter devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up to 26 weeks
Participants receive either XC001 gene therapy delivered via a cardiac catheter or a sham catheterization procedure without injections.
1 treatment visit followed by regular follow-up visits over 26 weeks
Duration - Up to 26 weeks extension after initial 26 weeks
Participants are monitored for safety and efficacy outcomes after the treatment period, with an optional 26-week extension.
Regular follow-up visits during extension period
Trial Site Locations
Total: 1 location
1
Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
D
Dawn VP Clinical Operation, MSc.
B
Brenda Senior Director Clinical Operations
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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