Research Study: NanoCor
Condition:
heart failure
Study Sponsor: NanoCor Therapeutics, Inc.
Study Investigator: Jay Traverse, MD
Study Contact: Anthony Brown-Norton
Anthony.Brown-Norton@allina.com
612-863-6571
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).
Eligibility Criteria:

  • Age >18 years of age.
  • Chronic non-ischemic cardiomyopathy.
  • LVEF ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment.
  • NYHA Class III HF for a minimum of 6 months HF despite appropriate medical therapy (defined below):
    • Treatment with appropriate HF therapy as tolerated, including, but not limited to:
    • Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment. May also receive aldosterone antagonist therapy. Doses of the above medications must be stable for ≥ 30 days prior to enrollment; and
    • Cardiac resynchronization therapy (CRT), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment.
  • Females of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
    • Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration.
    • Intrauterine device in place for at least 90 days prior to receiving IP.
    • Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP.
    • Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving IP). Females are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject.
    • Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP administration.
    • Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are started less than 90 days prior to receiving IP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives.
  • Males subjects capable of fathering a child:
    • Must agree to use a condom from IP administration through 6 months after the time of IP administration.
    • Must agree not to donate sperm for 6 months after time of receiving IP.
    • Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP is an acceptable form of contraception.
    • Males who claim abstinence as their method of contraception are allowed provided they agree to use barrier methods should they become sexually active from screening through 6 months after receiving IP. Males are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject.
  • Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form.
  • Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!