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Gene Therapy Trial Report

Summary

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


NCTID NCT04125732 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Coronary Artery Disease, Ischemia, Angina Refractory, Cardiovascular Diseases, Heart Diseases
Disease Ontology Term DOID:114
Compound Name XC001
Compound Alias Encoberminogene rezmadenovec
Sponsor XyloCor Therapeutics, Inc.
Funder Type Industry
Recruitment Status
Completed
Enrollment Count 41 (ACTUAL)
Results Posted Not Available

Therapy Information


Target Gene/Variant VEGF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intramyocardial
Drug Product Type Viral vector
Delivery System Viral transduction
Vector Type Ad5
Editor Type none
Dose 1 1E9 vp
Dose 2 1E10 vp
Dose 3 4E10 vp
Dose 4 1E11 vp (Expansion Dose)

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2019-10-04
Completion Date 2023-05-30
Last Update 2024-01-30

Participation Criteria


Eligible Age 18 Years - 80 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
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
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 16
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates First patient dosed in Phase 2b trial in July 2025

Resources/Links