Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI

Korábbi kezelés

• Planned or conducted thrombolytic therapy for treatment of this STEMI event
• Previous major vascular intervention within the last 4 weeks
• Major surgery within the last 6 weeks
• Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs, or colchicine).
• Participation in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.

Más betegség

• Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
• Severe aortic or mitral valve disease
• Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
• Major hemodynamic instability or uncontrolled ventricular arrhythmias
• Evidence of an active gastrointestinal or urogenital bleeding
• Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
• Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA.
• Active malignancy, excluding carcinoma in situ [any location] or localized non-melanoma skin cancer
• Life expectancy of less than 1 year due to non-cardiac pathology
• History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media)

Laborértékek

• Known severe renal (creatinine clearance <30 mL/min) or hepatic insufficiency as well as alanine transaminase (ALT) elevation ≥ 3x upper limit of normal; isolated AST-elevation is not considered an exclusion criterion from study participation

Egyéb

• An individual fulfilling any of the following criteria is to be excluded from enrollment in the study:
• Planned or conducted coronary artery bypass graft
• Neutropenia (<1,500/mm3 or <1,000/mm3 in Black/African American patients).
• Body weight >300 pounds (weight limit of the PET/CT table)
• Any clinically significant abnormality identified at the time of Screening that in the judgment of the Investigator, or any sub-Investigator would preclude safe completion of the study

• Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
• TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
• Symptom onset prior to PCI of ≤12 hours
• Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
• Ability to infuse study drug within 12 hours of PCI
• Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
• Capable of completing study visits
• Females participating in the study must meet one of the following criteria:
  • Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
  • Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
  • If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) until 30 days after the treatment
• Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment