Clinical trial NCT06788431: A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS
Official title: An IIT Clinical Study to Evaluate the Efficacy and Safety of IMC-001 for Injection on Improved Atherosclerotic Plaque Stability in Patients Receiving Optimal Medical Therapy Following a Recent Acute Coronary Syndrome (ACS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atherosclerosis
Keywords: Acute coronary syndrome
atherosclerosis
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
Collaborators: name: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
name: The First Affiliated Hospital of Nanyang Medical College
name: Renji Hospital, Shanghai
First posted: 2025-01-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group was given IMC-001 and the optimal drug treatment, and 8 subjects were included, and the control group was given only the optimal drug treatment, and 6 subjects were included.
Primary purpose: TREATMENT

Brief summary: This study is an IIT clinical study to evaluate the efficacy and safety of IMC-001 for injection on improved atherosclerotic plaque stability in patients receiving optimal medical therapy after a recent acute coronary syndrome (ACS). The study was a single-center, simple randomized, controlled study, in which the experimental group was given IMC-001 and the best drug treatment, and 8 subjects were included, and the control group was given only the best drug treatment, and 6 subjects were included.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 75 years old, male or female;
2. Patients with recent (within 30 days prior to enrollment) who have had acute coronary syndrome;
3. CTA examination of the presence of at least one measurable target vessel segment in the coronary artery, and the following two conditions must be met at the same time: the total volume of plaques with calcified volume accounting for \<50%, and the presence of low-density attenuated plaques (LAP) that meet the definition of CTA;
4. Subjects understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot enter this study:

1. Those who have had cerebral infarction or TIA in the past 12 months.
2. Myocardial infarction within the past 12 months (excluding acute myocardial infarction occurred within 1 month before this dose).
3. Patients who have received CABG, heart transplantation, SAVR/TAVR, etc. (patients who have undergone PCI in the past can be included); or patients who plan to undergo treatment such as CABG, PCI, heart transplantation, SAVR/TAVR, etc. during the study.
4. Recurrent episodes, severe symptoms, and arrhythmias that do not respond to drug therapy within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, and paroxysmal supraventricular tachycardia.
5. ECG showing prolonged QT interval, i.e., QTc interval ≥450 ms for males and 470 ms ≥for females, or a family history of long QT syndrome (grandparents, parents, and siblings).
6. New York Heart Association (NYHA) Class III. congestive heart failure and above.
7. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or history of spontaneous bleeding of any severity within 2 months prior to enrollment.
8. Current active lung disease, including but not limited to interstitial lung disease or pneumonia, pulmonary fibrosis, etc.
9. Severe infection within 4 weeks prior to the first dose or active infection at screening, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
10. Under the premise of no blood transfusion within 7 days, abnormal laboratory indicators include but are not limited to: neutrophil \<1.5×109/L, hemoglobin \<100 g/L, platelet count ≤ 100×109/L, total bilirubin \>1.5×ULN, international normalized ratio (INR) \>2×ULN or activated partial thromboplastin time (APTT) \>2×ULN, aspartate aminotransferase (AST) \>2×ULN and alanine aminotransferase (ALT) \>2×ULN , serum creatinine \> 1.5× ULN.
11. Known subject has a previous allergy to a large molecule protein preparation/monoclonal antibody, known allergy to the investigational drug or its excipients or the same type of drug.
12. Those who have donated or lost ≥ 400 mL of blood within 3 months prior to dosing, received blood transfusion or used blood products.
13. Participation in any drug clinical trial or medical device clinical trial within 3 months prior to screening.
14. Those who have undergone major surgery within 3 months prior to screening or are expected to have major surgery during the study period, including the screening period (except for patients who have undergone PCI within the previous 3 months).
15. Other malignancies within the past 3 years, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other malignancies with low risk of metastasis and mortality (5-year survival rate \>90%) that have received curative therapy.
16. Live vaccine or attenuated vaccine within 28 days prior to the first dose. However, inactivated vaccines can be administered.
17. Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive, and HBV DNA titer outside the normal range (HBcAb-positive patients need to undergo regular HBV DNA testing and receive antiviral prophylaxis); Hepatitis C virus (HCV-RNA) positive; Seropositive for human immunodeficiency virus (HIV). Positive Treponema pallidum antibody (TP-Ab) (if Treponema pallidum serology test is positive, further non-Treponema pallidum serology test is performed, and patients who are negative and judged by the investigator to have been infected with syphilis in the past but have been cured are eligible for inclusion).
18. Subjects with a history of drug abuse, alcohol abuse (alcohol abuse is defined as drinking 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine).
19. Pregnant or lactating females; Those who have a positive pregnancy test during the screening period.
20. Subjects who, in the opinion of the investigator, are not suitable to participate in the study.

Primary outcomes:
measure: The change in low-attenuated plaque volume (LAPV) of the target vessel segment of the coronary artery was assessed by CT angiography (CTA).
timeFrame: Day 85 Day 168
Secondary outcomes:
Other outcomes:
Locations:
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Shanghai
country: China
facility: Renji Hospital,Shanghai
state: Shanghai
Study officials:
References: