Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
XyloCor Therapeutics, Inc.
Study ID
NCT07118449
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • XC001 — DRUG
    22 injections will be administered at the end of the CABG procedure as a one time treatment.
  • A195/placebo — DRUG
    22 injections of A195/placebo will be administered at the end of the CABG procedure.

Study Details

This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo. Approximately 116 participants who have CAD and have been referred for revascularization by CABG and who have, according to assessment by stress imaging multiple myocardial segments that are substantially ischemic, and that are unlikely to be fully revascularized during CABG for technical reasons, including diffuse atherosclerosis, lack of conduits, or insufficient target vessels. Patients will be randomized in a 1:1 to XC001 or placebo injections during the final stages of the CABG procedure. Patients will have a baseline CMR at day 4-6 post CABG and additional assessments in the primary study period will be performed on Day 14, and Weeks 4, 12, and 26, (and during the extension period at 52 weeks).

Key Dates

Start date
Aug 27, 2025
Status verified
Aug 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Administration of study drug (XC001) at the end of the CABG procedure.
  • Placebo Comparator: Placebo group
    Administration of A195/placebo at the end of the CABG procedure.

Primary Outcome Measure

Change from Baseline (Day 4-6 CMR) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery. [ Time Frame: Week 26 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Christ HospitalCincinnatiOhio45202
Dawn Byrnes, VP Clinical Operations, MSc.
[email protected]
888-290-0081

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By research site
Christ Hospital· Cincinnati, OH

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