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

Primary Purpose

Coronary Artery Disease, Ischemia, Angina Refractory

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AdVEGFXC1
Sponsored by
XyloCor Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Refractory angina, Coronary Artery Disease, Gene Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • MedStar Washington Hospital Center
  • Cardiology Research Associates
  • University of Florida
  • James A. Haley VA Medical Center
  • Emory University
  • Minneapolis Heart Institute Foundation
  • Duke University
  • The Christ Hospital / The Lindner Research Center
  • University of Cincinnati
  • Cleveland Clinic
  • The Ohio State University
  • Lehigh Valley Health Network
  • Houston Methodist
  • Texas Heart Institute
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AdVEGFXC1 at 1x10^9 vp

AdVEGFXC1 at 1x10^10 vp

AdVEGFXC1 at 4x10^10 vp

AdVEGFXC1 at 1x10^11 vp

Arm Description

Outcomes

Primary Outcome Measures

Primary Endpoint (adverse events)
Safety, as assessed by adverse events and serious adverse events

Secondary Outcome Measures

Secondary Endpoint (Exercise tolerance test)
Exercise tolerance test
Secondary Endpoint (Seattle Angina Questionnaire)
Seattle Angina Questionnaire
Secondary Endpoint (Canadian Cardiovascular Society angina class)
Canadian Cardiovascular Society angina class
Secondary Endpoint (Angina episodes)
Angina episodes

Full Information

First Posted
October 4, 2019
Last Updated
June 20, 2023
Sponsor
XyloCor Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04125732
Brief Title
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Acronym
EXACT
Official Title
A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XyloCor Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
Detailed Description
This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemia, Angina Refractory, Cardiovascular Diseases, Heart Diseases
Keywords
Refractory angina, Coronary Artery Disease, Gene Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AdVEGFXC1 at 1x10^9 vp
Arm Type
Experimental
Arm Title
AdVEGFXC1 at 1x10^10 vp
Arm Type
Experimental
Arm Title
AdVEGFXC1 at 4x10^10 vp
Arm Type
Experimental
Arm Title
AdVEGFXC1 at 1x10^11 vp
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AdVEGFXC1
Other Intervention Name(s)
XC001
Intervention Description
AdVEGFXC1 at one of 4 doses
Primary Outcome Measure Information:
Title
Primary Endpoint (adverse events)
Description
Safety, as assessed by adverse events and serious adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary Endpoint (Exercise tolerance test)
Description
Exercise tolerance test
Time Frame
6 months
Title
Secondary Endpoint (Seattle Angina Questionnaire)
Description
Seattle Angina Questionnaire
Time Frame
6 months
Title
Secondary Endpoint (Canadian Cardiovascular Society angina class)
Description
Canadian Cardiovascular Society angina class
Time Frame
6 months
Title
Secondary Endpoint (Angina episodes)
Description
Angina episodes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cardiology Research Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
James A. Haley VA Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Christ Hospital / The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16791287
Citation
Stewart DJ, Hilton JD, Arnold JM, Gregoire J, Rivard A, Archer SL, Charbonneau F, Cohen E, Curtis M, Buller CE, Mendelsohn FO, Dib N, Page P, Ducas J, Plante S, Sullivan J, Macko J, Rasmussen C, Kessler PD, Rasmussen HS. Angiogenic gene therapy in patients with nonrevascularizable ischemic heart disease: a phase 2 randomized, controlled trial of AdVEGF(121) (AdVEGF121) versus maximum medical treatment. Gene Ther. 2006 Nov;13(21):1503-11. doi: 10.1038/sj.gt.3302802. Epub 2006 Jun 22.
Results Reference
background
PubMed Identifier
34224684
Citation
Povsic TJ, Henry TD, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Reinhardt RR, Dittrich HC, Traverse JH, Answini GA, Mokadam NA. Epicardial delivery of XC001 gene therapy for refractory angina coronary treatment (The EXACT Trial): Rationale, design, and clinical considerations. Am Heart J. 2021 Nov;241:38-49. doi: 10.1016/j.ahj.2021.06.013. Epub 2021 Jul 2.
Results Reference
derived

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

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