Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

Plain-language summary

This Phase 1/2 study examines the gene therapy XC001 (AdVEGFXC1) in adults aged 18 to 80 with chronic angina caused by coronary artery disease who have no other treatment options. XC001 expresses human vascular endothelial growth factor (VEGF), intended to induce new blood vessel growth (angiogenesis), and participants receive one of four intramyocardial doses. The primary aim is to determine safety; participants must have angina refractory to drug therapy and be unsuitable for coronary bypass surgery or percutaneous coronary intervention.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

XyloCor Therapeutics, Inc.

Intervention

AdVEGFXC1 (XC001)

Start date

1/24/2020

Estimated completion

5/30/2023

Countries

United States

Related genes

Locations

• Stanford, United States
• Washington D.C., United States
• Daytona Beach, United States
• Gainesville, United States
• Tampa, United States
• Atlanta, United States
• Minneapolis, United States
• Durham, United States
• Cincinnati, United States
• Cincinnati, United States
• Cleveland, United States
• Columbus, United States
• Allentown, United States
• Houston, United States
• Houston, United States
• Seattle, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Males and females, age 18 to 80 years
* Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention
* Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris
* Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count \> 1.2 × 10\^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate \> 29 mL/minute/1.73 m2)
* Adequate birth control if of child-bearing potential
* Must be willing and able to provide informed consent

Exclusion Criteria:

* ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days
* New York Heart Association Function Class III or IV or left ventricular ejection fraction \< 25% within the 6 weeks prior to the screening visit
* HbA1c ≥ 8.5%, SBP \<90 or \>180 mmHg, DBP \>100 mmHg
* Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study