NCT07610538 Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
| NCT ID | NCT07610538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-03-31 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07610538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610538 currently recruiting?
Yes, NCT07610538 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cambridge University Hospitals NHS Foundation Trust to inquire about joining.
Where is the NCT07610538 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom, Cambridge, United Kingdom.
Who is sponsoring the NCT07610538 clinical trial?
NCT07610538 is sponsored by Cambridge University Hospitals NHS Foundation Trust. The trial plans to enroll 24 participants.