At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Interleukin-2 (Aldesleukin) (drug), Standard care (procedure), Interleukin-2 (Aldesleukin) (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Interleukin-2 (Aldesleukin) — drug: 5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed · Standard care — procedure: Standard care for patients with coronary artery disease undergoing CABG surgery · Interleukin-2 (Aldesleukin) — drug: 5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 24
- Started
- 2026-03-31
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for coronary artery disease
- • NA - 24 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with coronary artery disease
Where?
- • Cambridge - Royal Papworth Hospital NHS Foundation Trust
- • Cambridge - Addenbrooke's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
So far, our lab has looked at Tregs and immune cells in the blood. The question remained whether ld-IL-2 can have the desired effect on Tregs in tissues, particularly the vasculature and cardiac tissues, where they could promote tissue repair and potentially improve clinical outcomes for patients after a myocardial infarction which causes significant tissue damage. Clinically, this could lead to lower rates of heart failure. In both the LILACS and IVORY trials, the effect measured was on circulating Tregs, whilst the effect of ld-IL-2 on tissue resident immune cells remains unknown. Therefore, the aims of the study are to understand the effect of treatment with ld-IL-2 on tissue-resident immune cells in the context of ischaemic heart disease and acute MI where there has been acute tissue damage. This includes: 1. Assessment if ld-IL-2, given systemically to patients at our proposed doses, can alter Tregs in the vasculature and cardiac tissues to exhibit a tissue repair and anti-inflammatory phenotype 2. Studying the relationship between the vasculature, cardiac tissues and circulating immune cells after systemic ld-IL-2 administration.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Aged over 18 years old
- ✓Undergoing CABG surgery
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Royal Papworth Hospital NHS Foundation Trust
Cambridge CB2 0AY, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
