Coronary Artery Disease (CAD)Phase 2EXACT-CABGNCT07118449
Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG
A Phase 2 study testing XC001 in people with Coronary Artery Disease (CAD), run by XyloCor Therapeutics, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- XC001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males and females, age 18 to 80 years, inclusive, at the time of signing the ICF.
- 2. Has multivessel epicardial CAD and is clinically indicated for coronary revascularization that is best treated via elective (stand-alone, i.e., not associated with valve surgery) and on-pump CABG at high risk for incomplete revascularization as assessed by local cardiothoracic surgeon and independent Eligibility Review Committee (ERC).
- 3. LVEF by standard quantitative imaging technique of 25% to 50%. 4. Anatomical findings on coronary angiography and/or stress imaging that increase the likelihood of incomplete revascularization post-CABG and that supply LV segments determined to be ischemic on pre-operative stress imaging (detailed in the ERC Charter). These include, but are not exclusively:
- Diffuse distal coronary artery atherosclerotic disease and/or small coronary target vessels deemed unsuitable for grafting within a major coronary artery b. Multiple segmental lesions along a defined major coronary artery c. In a major coronary artery - "missing vessel" where the vessel is not seen on an angiogram d. Major coronary arteries that are ungraftable due to a long segment of failed stents e. High likelihood of available conduits being insufficient for target lesions in major coronary arteries f. Ischemic regions identified on stress imaging that are not likely to be benefited by CABG (ischemic region greater in size than that portion of myocardium supplied by the target vessel(s) that will likely be successfully grafted). Further detailed in the ERC Charter.
- 5. All participants capable of procreation with their partners must agree to use a highly effective and medically accepted method of contraception for 6 months following the study procedure (Day 1) to avoid pregnancy. This is not required of female participants who are either:
- Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal replacement surgery; OR
- Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening 6. Female participants agree to not donate oocytes and male participants must agree not to donate sperm for 6 months following administration of investigational protocol.
- 7. Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.
Who cannot join
- 1. Any of the following:
- ST elevation myocardial infarction (STEMI) or cerebral vascular accident within the past 60 days prior to the Screening visit;
- Sustained, current systolic blood pressure (BP) less than 90 mmHg or uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment;
- Current untreated malignant ventricular arrhythmia;
- Congestive heart failure (HF) within the last 60 days defined as New York Heart Association Functional Class IV;
- Current mitral or aortic valvular heart disease requiring mechanical intervention anticipated during the study period (including percutaneous intervention).
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- 2. Participants with uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy).
- 3. Participants with documented, active proliferative retinopathy from any cause (ETDRS [Early Treatment Diabetic Retinopathy Study] score >35).
- 4. Indication for combination of CABG with any valvuloplasty or valvular replacement and/or arrhythmia surgery (for instance a Cox-maze IV surgical procedure for atrial fibrillation).
- 5. Body mass index (BMI) > 45 kg/m2. 6. Hemoglobin < 10 g/dL, absolute neutrophil count < 1.2 × 103 per µL, platelet count < 75,000 per µL, alanine aminotransferase and aspartate aminotransferase > 3 × upper limit of normal (ULN), total bilirubin > 2 × ULN unless the participant has a previously known history of Gilbert's syndrome 7. Diabetic individuals with glycosylated hemoglobin (HbA1c) > 9.5% or with active proliferative diabetic retinopathy.
- 8. A history or evidence of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV), active hepatitis B virus (HBV).
- 9. Severely immune compromised participants, including participants currently treated with chronic high dose of corticosteroid therapy and/or cytostatic (oncolytic) therapy.
- 10. Diagnosis of, or treatment for, any cancer within the last 5 years, except for basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. Past medical history of cancer is not exclusionary as long as the participant has been disease free for at least 5 years since the time of diagnosis and treatment.
- 11. Known hypersensitivity or any other contraindication to the formulation buffer used to suspend the viral vector or contrast agents used in any of the radiographic procedures, or contraindication to general anesthesia.
- 12. Pregnancy or currently lactating. 13. Absolute contraindication to CMR: metallic implant (including pacemaker, or implantable cardioverter defibrillator), uncontrolled claustrophobia, severe renal dysfunction (eGFR<30 mL/minute/1.73 m2), or on renal dialysis.
- 14. Recurrent or persistent atrial fibrillation with rapid ventricular response (>100 bpm) that precludes the analysis of CMR stress imaging (to assess ischemic burden, cardiac dimensions and cardiac function).
- 15. Receiving an investigational intervention or participating in another clinical study within 30 days or within 5 half-lives (whichever is longer) of the drug prior to Screening. An exception may be made if the individual is enrolled in a nontherapeutic observational study (registry) or the observational portion of a therapeutic study where the sponsoring authority authorizes enrollment.
- 16. Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the participant was randomized to the placebo control group and did not receive active gene transfer agent, the participant may be considered for this study.
- 17. Has a serious or unstable medical (including unstable chronic obstructive pulmonary disease under adequate treatment) or psychological condition (including drugs or alcohol abuse) that, in the opinion of the Investigator (with input from the ERC as appropriate), would compromise the participant's safety or successful participation in the study or interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Christ Hospital
Cincinnati, Ohio, 45202
Dawn Byrnes, VP Clinical Operations, MSc., 888-290-0081, dawn.byrnes@xylocor.com
About this study
Official title: A 26-Week (With 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients With Symptomatic Coronary Artery Disease With Left Ventricular Dysfunction at Risk for Incomplete Revascularization
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).
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- XC001, A195/placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC001Drug
22 injections will be administered at the end of the CABG procedure as a one time treatment.
A195/placeboDrug
22 injections of A195/placebo will be administered at the end of the CABG procedure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Administration of study drug (XC001) at the end of the CABG procedure. Receives: Drug: XC001 |
| Placebo group | Placebo comparator | Administration of A195/placebo at the end of the CABG procedure. Receives: Drug: A195/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden, as measured by the following:
- Global and segmental perfusion measured as sum of 32 subsegmental American Heart Association (AHA) LV segments with myocardial ischemia at 12- and 26-weeks follow-up compared to baseline (defined as a subsegment with myocardial ischemia without subendocardial late gadolinium enhancement)
- Segmental myocardial blood flow measuring extent of ischemic defect in each of 16 (combined subendocardial and subepicardial) AHA LV segments defined as below at 12 and 26 weeks follow-up compared with Baseline:
- Segment is abnormal if one (subendocardial) or both subsegments are ischemic at Baseline
- Segment is defined as improved at follow-up if one or both subsegments normalize To qualify for analysis of the primary endpoint, at least 3 of 32 subsegments will have will have to be ischemic on the baseline CMR.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start27 Aug 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XyloCor Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118449
- Sponsor's protocol ID
- XC001-1003
- Other IDs
- 2025-521325-33-00, 2025
- Acronym
- EXACT-CABG
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-Week (With 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients With Symptomatic Coronary Artery Disease With Left Ventricular Dysfunction at Risk for Incomplete Revascularization
- ClinicalTrials.gov ID
- NCT07118449
- Acronym / sponsor ID
- EXACT-CABG / XC001-1003
- Conditions
- Coronary Artery Disease (CAD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- XyloCor Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: XC001Administration of study drug (XC001) at the end of the CABG procedure. |
| Placebo group | Placebo comparator | Drug: A195/placeboAdministration of A195/placebo at the end of the CABG procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Males and females, age 18 to 80 years, inclusive, at the time of signing the ICF.
- 2. Has multivessel epicardial CAD and is clinically indicated for coronary revascularization that is best treated via elective (stand-alone, i.e., not associated with valve surgery) and on-pump CABG at high risk for incomplete revascularization as assessed by local cardiothoracic surgeon and independent Eligibility Review Committee (ERC).
- 3. LVEF by standard quantitative imaging technique of 25% to 50%. 4. Anatomical findings on coronary angiography and/or stress imaging that increase the likelihood of incomplete revascularization post-CABG and that supply LV segments determined to be ischemic on pre-operative stress imaging (detailed in the ERC Charter). These include, but are not exclusively:
- 5. All participants capable of procreation with their partners must agree to use a highly effective and medically accepted method of contraception for 6 months following the study procedure (Day 1) to avoid pregnancy. This is not required of female participants who are either:
- 7. Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.
Key exclusion criteria (19 listed)
- 1. Any of the following:
- 2. Participants with uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy).
- 3. Participants with documented, active proliferative retinopathy from any cause (ETDRS [Early Treatment Diabetic Retinopathy Study] score >35).
- 4. Indication for combination of CABG with any valvuloplasty or valvular replacement and/or arrhythmia surgery (for instance a Cox-maze IV surgical procedure for atrial fibrillation).
- 5. Body mass index (BMI) > 45 kg/m2. 6. Hemoglobin < 10 g/dL, absolute neutrophil count < 1.2 × 103 per µL, platelet count < 75,000 per µL, alanine aminotransferase and aspartate aminotransferase > 3 × upper limit of normal (ULN), total bilirubin > 2 × ULN unless the participant has a previously known history of Gilbert's syndrome 7. Diabetic individuals with glycosylated hemoglobin (HbA1c) > 9.5% or with active proliferative diabetic retinopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC00122 injections will be administered at the end of the CABG procedure as a one time treatment. | Drug | Treatment group |
| A195/placebo22 injections of A195/placebo will be administered at the end of the CABG procedure. | Drug | Placebo group |
Primary outcome
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
Endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden, as measured by the following: * Global and segmental perfusion measured as sum of 32 subsegmental American Heart Association (AHA) LV segments with myocardial ischemia at 12- and 26-weeks follow-up compared to baseline (defined as a subsegment with myocardial ischemia without subendocardial late gadolinium enhancement) * Segmental myocardial blood flow measuring extent of ischemic defect in each of 16 (combined subendocardial and subepicardial) AHA LV segments defined as below at 12 and 26 weeks follow-up compared with Baseline: * Segment is abnormal if one (subendocardial) or both subsegments are ischemic at Baseline * Segment is defined as improved at follow-up if one or both subsegments normalize To qualify for analysis of the primary endpoint, at least 3 of 32 subsegments will have will have to be ischemic on the baseline CMR.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XC001 in people with Coronary Artery Disease (CAD), run by XyloCor Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawn Byrnes, VP Clinical Operations, MSc. (888-290-0081, dawn.byrnes@xylocor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.