Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells

NCT07610538 | Recruiting

• 1 other identifier: A097309
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The primary goals of this study are to compare the differences in tissue-resident Treg gene signature for activation, proliferation, and suppressive function using single-cell/-nucleus RNA sequencing in patients treated with ld-IL-2 compared to control grouped by individual tissue beds from in and around the heart. Additionally, tissue-resident Tregs will be compared to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2 on the two compartments.

Conditions

Coronary Artery Disease; Myocardial Infarction (MI); CABG

Keywords

Interleukin-2; IL-2; MI; Myocardial infarction; CABG; Coronary artery bypass graft

Outcome Measures

Primary Outcomes (2)

• Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control

  Assessing Tregs from the various tissue beds and comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies

  Time of surgery

• Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2

  Comparing the tissue Tregs against blood Tregs from the same patient by comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies and looking for differences between the two compartments.

  Time of surgery

Secondary Outcomes (4)

• Difference in inflammatory T effector cells

  Time of surgery

• Difference in other immune cells

  Time of surgery

• Comparing T cell receptor repertoire

  Time of surgery

• Comparing tissue-resident immune cells to circulating immune cells

  Time of surgery

Other Outcomes (5)

• Systemc biomarkers of inflammation and tissue damage

  Time of surgery

• Non-immune cells and cardiomyocytes

  Time of surgery

• Characterise tissue-level gene signatures

  Time of surgery

Study Arms (3)

Low dose interleukin-2 at dose 1.5MIU

EXPERIMENTAL

Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 1.5MIU will be used for all daily and, if needed, weekly doses

Drug: Interleukin-2 (Aldesleukin); Procedure: Standard care

Low dose interleukin-2 at dose 2.0MIU

EXPERIMENTAL

Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 2.0MIU will be used for all daily and, if needed, weekly doses

Procedure: Standard care; Drug: Interleukin-2 (Aldesleukin)

Control

ACTIVE COMPARATOR

Standard of care treatment

Procedure: Standard care

Interventions

Interleukin-2 (Aldesleukin) DRUG

5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed

Also known as: 1.5MIU

Low dose interleukin-2 at dose 1.5MIU

Standard care PROCEDURE

Standard care for patients with coronary artery disease undergoing CABG surgery

Control; Low dose interleukin-2 at dose 1.5MIU; Low dose interleukin-2 at dose 2.0MIU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years old
• Undergoing CABG surgery

You may not qualify if:

• Critical left main stem coronary disease
• Severe valvular disease (for example 'severe' aortic stenosis as classified on echocardiogram report)
• Haemodynamic instability caused by arrhythmia requiring cardioversion in the current admission
• Non-sustained ventricular tachycardia of \>10 beats in the last 48 hours
• Autoimmune disease
• Any regular immunosuppressive treatment \[Inhaled or topical steroids are permissible\]
• Known active hepatic disease or alanine aminotransferase (ALT) \> 3xULN
• Severe chronic kidney disease (defined as eGFR \< 30 ml/min/1.73m2)
• Allergy or intolerance to aldesleukin
• Signs and symptoms of active infection
• History of human immunodeficiency virus (HIV), hepatitis B or C
• Current malignancy requiring active treatment
• Vaccine within 4 weeks prior to screening
• Women of child-bearing potential and pregnancy (women must be either postmenopausal (defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile (e.g. age appropriate (\>55 years old), history of vasomotor symptoms) or having documented hysterectomy and/or bilateral oophorectomy)
• Women who are breast-feeding

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Royal Papworth Hospital: collaborator

Study Sites (2)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

aldesleukin; Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BHF Intermediate Fellow

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-03

Locations

GB (2)