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

20. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Storbritannia, CB2 0QQ
        • Rekruttering
        • Addenbrooke's Hospital
        • Ta kontakt med:
      • Cambridge, Cambridgeshire, Storbritannia, CB2 0AY
        • Rekruttering
        • Royal Papworth Hospital NHS Foundation Trust
        • Ta kontakt med:
          • Ali Al-Hadithi, MB BChir
          • Telefonnummer: 01223768678 Royal Papworth Hospital NHS Fo
          • E-post: abaka2@cam.ac.uk

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kontroll
Standard behandling
Fremgangsmåte: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Eksperimentell: 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
Legemiddel: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andre navn:
  • 1.5MIU
Fremgangsmåte: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Legemiddel: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andre navn:
  • 2.0MIU
Eksperimentell: 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
Legemiddel: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andre navn:
  • 1.5MIU
Fremgangsmåte: Standard care
Standard care for patients with coronary artery disease undergoing CABG surgery
Legemiddel: Interleukin-2 (Aldesleukin)
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andre navn:
  • 2.0MIU

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Samarbeidspartnere

Royal Papworth Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. mars 2026

Primær fullføring (Antatt)

1. november 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A097309

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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