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Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells (Leuk-ALIVE)

20. maj 2026 opdateret af: Tian Zhao, Cambridge University Hospitals NHS Foundation Trust
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
        • Rekruttering
        • Addenbrooke's Hospital
        • Kontakt:
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0AY
        • Rekruttering
        • Royal Papworth Hospital NHS Foundation Trust
        • Kontakt:
          • Ali Al-Hadithi, MB BChir
          • Telefonnummer: 01223768678 Royal Papworth Hospital NHS Fo
          • E-mail: abaka2@cam.ac.uk

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Styring
Standardbehandlingsbehandling
Procedure: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Eksperimentel: Low dose interleukin-2 at dose 1.5MIU
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
Medicin: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andre navne:
  • 1.5MIU
Procedure: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Medicin: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andre navne:
  • 2.0MIU
Eksperimentel: Low dose interleukin-2 at dose 2.0MIU
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
Medicin: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andre navne:
  • 1.5MIU
Procedure: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Medicin: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andre navne:
  • 2.0MIU

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
Tidsramme: 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
Time of surgery
Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2
Tidsramme: 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.
Time of surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in inflammatory T effector cells
Tidsramme: Time of surgery
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)
Time of surgery
Difference in other immune cells
Tidsramme: Time of surgery
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)
Time of surgery
Comparing T cell receptor repertoire
Tidsramme: Time of surgery
Comparing differences in T cell receptor (TCR) repertoire using TCR sequencing technologies between the 3 patient groups (control, 1.5MIU and 2.0MIU)
Time of surgery
Comparing tissue-resident immune cells to circulating immune cells
Tidsramme: Time of surgery
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.
Time of surgery

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Systemc biomarkers of inflammation and tissue damage
Tidsramme: Time of surgery
Compare blood-based inflammation markers and assays between the three patient groups (control, 1.5MIU, 2.0MIU)
Time of surgery
Non-immune cells and cardiomyocytes
Tidsramme: Time of surgery
Compare stromal and myocardial cells on sc/snRNA-seq technologies between the three patient groups (control, 1.5MIU, 2.0MIU)
Time of surgery
Characterise tissue-level gene signatures
Tidsramme: Time of surgery
Tissue-level RNA expression will be evaluated on sc/snRNA-sequencing technologies
Time of surgery
Gut microbiota
Tidsramme: Time of surgery
Compare stool-based analysis of microbiota between the three patient groups (control, 1.5MIU, 2.0MIU)
Time of surgery
Safety and tolerability of IL-2 in patients after acute MI undergoing CABG
Tidsramme: Time of surgery
Safety and tolerability will be assessed by recording adverse events (AEs) and reviewing patient notes.
Time of surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Samarbejdspartnere

Royal Papworth Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. marts 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A097309

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