Coronary Artery DiseaseLeuk-ALIVENCT07610538
Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
A study testing Interleukin-2 (Aldesleukin) in people with Coronary Artery Disease and Myocardial Infarction (MI), run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction (MI), CABG
- What is being tested?
- Interleukin-2 (Aldesleukin)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 31 Mar 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years old
- Undergoing CABG surgery
Who cannot join
- 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]
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
Ali Al-Hadithi, MB BChir, Royal Papworth Hospital NHS Fo ext. 01223768678, abaka2@cam.ac.uk
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Ali Al-Hadithi, MB BChir, 01223768678, abaka2@cam.ac.uk
About this study
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.
Read the detailed description
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:
- 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
- Studying the relationship between the vasculature, cardiac tissues and circulating immune cells after systemic ld-IL-2 administration.
- Conditions
- Coronary Artery Disease, Myocardial Infarction (MI), CABG
- Being tested
- Interleukin-2 (Aldesleukin), Standard care
- Keywords
- Interleukin-2, IL-2, MI, Myocardial infarction, CABG, Coronary artery bypass graft
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 (Aldesleukin)Drug
Also called 1.5MIU
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Standard careProcedure or surgery
Standard care for patients with coronary artery disease undergoing CABG surgery
Interleukin-2 (Aldesleukin)Drug
Also called 2.0MIU
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
| Study group | Role | What they receive |
|---|---|---|
| Low dose interleukin-2 at dose 1.5MIU | Experimental | Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 1.5MIU will be used for all daily and, if needed, weekly doses Receives: Drug: Interleukin-2 (Aldesleukin); Procedure: Standard care |
| Low dose interleukin-2 at dose 2.0MIU | Experimental | Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 2.0MIU will be used for all daily and, if needed, weekly doses Receives: Procedure: Standard care; Drug: Interleukin-2 (Aldesleukin) |
| Control | Active comparator | Standard of care treatment Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
Assessing Tregs from the various tissue beds and comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies
Measured: Time of surgery
Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2
Comparing the tissue Tregs against blood Tregs from the same patient by comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies and looking for differences between the two compartments.
Measured: Time of surgery
Secondary outcomes (4)
Difference in inflammatory T effector cells
Comparing differential gene expression using sc/snRNA-sequencing technologies from isolated effector T cells between the 3 patient groups (control, 1.5MIU and 2.0MIU)
Measured: Time of surgery
Difference in other immune cells
Comparing differential gene expression using sc/snRNA-sequencing technologies from other immune cells (e.g. B cells) between the 3 patient groups (control, 1.5MIU and 2.0MIU)
Measured: Time of surgery
Comparing T cell receptor repertoire
Comparing differences in T cell receptor (TCR) repertoire using TCR sequencing technologies between the 3 patient groups (control, 1.5MIU and 2.0MIU)
Measured: Time of surgery
Comparing tissue-resident immune cells to circulating immune cells
Tissue-resident immune cells will be compared to peripheral/circulating immune cells from the same patient using sc/snRNA-seq technologies to compare the differential effect of ld-IL-2 on the two compartments.
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start31 Mar 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Papworth Hospital
- Responsible party
- Principal investigator, Tian Zhao, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610538
- Sponsor's protocol ID
- A097309
- Acronym
- Leuk-ALIVE
- Status last verified
- Mar 2026
- First submitted
- 20 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
- ClinicalTrials.gov ID
- NCT07610538
- Acronym / sponsor ID
- Leuk-ALIVE / A097309
- Conditions
- Coronary Artery Disease, Myocardial Infarction (MI), CABG
- Keywords
- Interleukin-2, IL-2, MI, Myocardial infarction, CABG, Coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Papworth Hospital
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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
- Studying the relationship between the vasculature, cardiac tissues and circulating immune cells after systemic ld-IL-2 administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose interleukin-2 at dose 1.5MIU | Experimental | Drug: Interleukin-2 (Aldesleukin), Procedure: Standard careCommercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 1.5MIU will be used for all daily and, if needed, weekly doses |
| Low dose interleukin-2 at dose 2.0MIU | Experimental | Procedure: Standard care, Drug: Interleukin-2 (Aldesleukin)Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Dose of 2.0MIU will be used for all daily and, if needed, weekly doses |
| Control | Active comparator | Procedure: Standard careStandard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged over 18 years old
- Undergoing CABG surgery
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin-2 (Aldesleukin)Also: 1.5MIU5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed | Drug | Low dose interleukin-2 at dose 1.5MIU |
| Standard careStandard care for patients with coronary artery disease undergoing CABG surgery | Procedure or surgery | Control, Low dose interleukin-2 at dose 1.5MIU, Low dose interleukin-2 at dose 2.0MIU |
| Interleukin-2 (Aldesleukin)Also: 2.0MIU5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed | Drug | Low dose interleukin-2 at dose 2.0MIU |
Primary outcome
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
Time frame: Time of surgery
Assessing Tregs from the various tissue beds and comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies
Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2
Time frame: Time of surgery
Comparing the tissue Tregs against blood Tregs from the same patient by comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies and looking for differences between the two compartments.
4 secondary outcomes
Difference in inflammatory T effector cells
Time frame: Time of surgery
Difference in other immune cells
Time frame: Time of surgery
Comparing T cell receptor repertoire
Time frame: Time of surgery
Comparing tissue-resident immune cells to circulating immune cells
Time frame: Time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin-2 (Aldesleukin) in people with Coronary Artery Disease and Myocardial Infarction (MI), run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control (time frame: Time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.