RECRUITING

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

Conditions

STEMI STEMI (ST Elevation MI)STEMI - ST Elevation Myocardial Infarction (MI)Stent Implantation atibuclimab IC14 monoclonal antibody against CD14 anti-CD14 antiinflammatory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).

Official Title

Phase 1b Pilot Study of Atibuclimab (IC14) for Treatment of ST-Elevation Myocardial Infarction

Quick Facts

Study Start:2025-02-06

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06678074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG. 2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram 3. Symptom onset prior to PCI of ≤12 hours 4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI) 5. Ability to infuse study drug within 12 hours of PCI 6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms) 7. Capable of completing study visits 8. Females participating in the study must meet one of the following criteria: 1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year); 2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or 3. 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 9. Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment	1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock) 2. Severe aortic or mitral valve disease 3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support 4. Major hemodynamic instability or uncontrolled ventricular arrhythmias 5. Planned or conducted thrombolytic therapy for treatment of this STEMI event 6. Planned or conducted coronary artery bypass graft 7. Previous major vascular intervention within the last 4 weeks 8. Major surgery within the last 6 weeks 9. Evidence of an active gastrointestinal or urogenital bleeding 10. 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). 11. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus). 12. Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA. 13. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African American patients). 14. Active malignancy, excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer 15. 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. 16. Life expectancy of less than 1 year due to non-cardiac pathology 17. History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media) 18. Body weight \>300 pounds (weight limit of the PET/CT table) 19. 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 20. 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

Inclusion Criteria

Exclusion Criteria

1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
3. Symptom onset prior to PCI of ≤12 hours
4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
5. Ability to infuse study drug within 12 hours of PCI
6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
7. Capable of completing study visits
8. Females participating in the study must meet one of the following criteria:
1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
3. 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
9. Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment

1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
2. Severe aortic or mitral valve disease
3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Planned or conducted thrombolytic therapy for treatment of this STEMI event
6. Planned or conducted coronary artery bypass graft
7. Previous major vascular intervention within the last 4 weeks
8. Major surgery within the last 6 weeks
9. Evidence of an active gastrointestinal or urogenital bleeding
10. 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).
11. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
12. Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA.
13. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African American patients).
14. Active malignancy, excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer
15. 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.
16. Life expectancy of less than 1 year due to non-cardiac pathology
17. History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media)
18. Body weight \>300 pounds (weight limit of the PET/CT table)
19. 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
20. 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

Contacts and Locations

Study Contact

Garry Redlich

CONTACT

(303)775-8210

garry.redlich@implicitbioscience.com

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Implicit Bioscience

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-02-06

Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

atibuclimab
IC14
monoclonal antibody against CD14
anti-CD14
antiinflammatory

Additional Relevant MeSH Terms

STEMI
STEMI (ST Elevation MI)
STEMI - ST Elevation Myocardial Infarction (MI)
Stent Implantation