Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regu… (NCT07610538) | Clinical Trial Compass
RecruitingNot Applicable
Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
United Kingdom24 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
Timeframe: Time of surgery
2
Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2
Timeframe: Time of surgery
Trial details
NCT IDNCT07610538
SponsorCambridge University Hospitals NHS Foundation Trust