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Clinical Trial Report

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
Indication Coronary Artery Disease, Ischemia, Angina Refractory, Cardiovascular Diseases, Heart Diseases
Compound Name Encoberminogene rezmadenovec/XC001
Sponsor XyloCor Therapeutics, Inc.
Funder Type Industry
Status
Completed
Enrollment Count 41

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
Target Tissue/Cell
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)
Dose 5

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
Eligible Sex ALL

Locations


No.of Trial Sites 16
Locations United States

Regulatory Information


Has US IND True
Recent Updates

Resources/Links