Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells (Leuk-ALIVE)
20. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
24
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
Cambridgeshire
-
Cambridge, Cambridgeshire, Vereinigtes Königreich, CB2 0QQ
- Rekrutierung
- Addenbrooke's Hospital
-
Kontakt:
- Ali Al-Hadithi, MB BChir
- Telefonnummer: 01223768678
- E-Mail: abaka2@cam.ac.uk
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Cambridge, Cambridgeshire, Vereinigtes Königreich, CB2 0AY
- Rekrutierung
- Royal Papworth Hospital NHS Foundation Trust
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Kontakt:
- Ali Al-Hadithi, MB BChir
- Telefonnummer: 01223768678 Royal Papworth Hospital NHS Fo
- E-Mail: abaka2@cam.ac.uk
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Kontrolle
Standardbehandlung
|
Standard care for patients with coronary artery disease undergoing CABG surgery
|
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Experimental: 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
|
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andere Namen:
Standard care for patients with coronary artery disease undergoing CABG surgery
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andere Namen:
|
|
Experimental: 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
|
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Andere Namen:
Standard care for patients with coronary artery disease undergoing CABG surgery
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
Zeitfenster: Time of surgery
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Assessing Tregs from the various tissue beds and comparing differential gene expression markers for tissue healing and inflammation using sc/snRNA-sequencing technologies
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Time of surgery
|
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Comparing tissue-resident Tregs to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2
Zeitfenster: Time of surgery
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Difference in inflammatory T effector cells
Zeitfenster: 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
Zeitfenster: 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
|
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Comparing T cell receptor repertoire
Zeitfenster: Time of surgery
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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
|
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Comparing tissue-resident immune cells to circulating immune cells
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Systemc biomarkers of inflammation and tissue damage
Zeitfenster: Time of surgery
|
Compare blood-based inflammation markers and assays between the three patient groups (control, 1.5MIU, 2.0MIU)
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Time of surgery
|
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Non-immune cells and cardiomyocytes
Zeitfenster: Time of surgery
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Compare stromal and myocardial cells on sc/snRNA-seq technologies between the three patient groups (control, 1.5MIU, 2.0MIU)
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Time of surgery
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Characterise tissue-level gene signatures
Zeitfenster: Time of surgery
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Tissue-level RNA expression will be evaluated on sc/snRNA-sequencing technologies
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Time of surgery
|
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Gut microbiota
Zeitfenster: Time of surgery
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Compare stool-based analysis of microbiota between the three patient groups (control, 1.5MIU, 2.0MIU)
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Time of surgery
|
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Safety and tolerability of IL-2 in patients after acute MI undergoing CABG
Zeitfenster: Time of surgery
|
Safety and tolerability will be assessed by recording adverse events (AEs) and reviewing patient notes.
|
Time of surgery
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
31. März 2026
Primärer Abschluss (Geschätzt)
1. November 2028
Studienabschluss (Geschätzt)
1. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
20. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Mai 2026
Zuerst gepostet (Tatsächlich)
28. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Mai 2026
Zuletzt verifiziert
1. März 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Herzkrankheiten
- Infarkt
- Nekrose
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Myokardischämie
- Ischämie
- Pathologische Zustände, Anzeichen und Symptome
- Koronare Herzkrankheit
- Herzinfarkt
- Verwaltung des Gesundheitswesens
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Qualität der Gesundheitsversorgung
- Qualitätsindikatoren, Gesundheitsversorgung
- Sorgfalt
- Aldesleukin
Andere Studien-ID-Nummern
- A097309
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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