Low-dose IL-2 after heart attack to study tissue-resident regulatory T cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effect of systemic low-dose Aldesleukin (IL-2) on tissue-resident regulatory T cells in patients undergoing CABG after myocardial infarction. Using single-cell and single-nucleus RNA sequencing, the study compares Treg signatures in heart-adjacent tissues to peripheral blood Tregs to see if ld-IL-2 promotes an anti-inflammatory, tissue-repairing phenotype. Participants receive ld-IL-2 alongside standard care, with assessments focused on tissue vasculature and cardiac tissues and their relationship to circulating immune cells. The investigation builds on prior work showing ld-IL-2 effects in blood, aiming to determine whether similar tissue-level effects occur and whether this could translate to improved clinical outcomes such as reduced heart failure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged over 18 years old
* Undergoing CABG surgery

Exclusion Criteria:

* 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

Where it's running

• Royal Papworth Hospital NHS Foundation Trust
  Cambridge, Cambridgeshire, United Kingdom Recruiting
• Addenbrooke's Hospital
  Cambridge, Cambridgeshire, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.