RecruitingNot ApplicableNCT07610538

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


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

24 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Aged over 18 years old
  • Undergoing CABG surgery

Exclusion Criteria16

  • 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
  • Clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study

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Interventions

DRUGInterleukin-2 (Aldesleukin)

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

PROCEDUREStandard care

Standard care for patients with coronary artery disease undergoing CABG surgery

DRUGInterleukin-2 (Aldesleukin)

5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed


Locations(2)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

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NCT07610538


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