Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells (Leuk-ALIVE)
2026年5月20日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
24
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Cambridgeshire
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Cambridge、Cambridgeshire、イギリス、CB2 0QQ
- 募集
- Addenbrooke's Hospital
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コンタクト：
- Ali Al-Hadithi, MB BChir
- 電話番号：01223768678
- メール：abaka2@cam.ac.uk
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Cambridge、Cambridgeshire、イギリス、CB2 0AY
- 募集
- Royal Papworth Hospital NHS Foundation Trust
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コンタクト：
- Ali Al-Hadithi, MB BChir
- 電話番号：01223768678 Royal Papworth Hospital NHS Fo
- メール：abaka2@cam.ac.uk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：コントロール
標準治療
|
Standard care for patients with coronary artery disease undergoing CABG surgery
|
|
実験的：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
他の名前：
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
他の名前：
|
|
実験的：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
他の名前：
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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in inflammatory T effector cells
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Systemc biomarkers of inflammation and tissue damage
時間枠：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
時間枠：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
時間枠：Time of surgery
|
Tissue-level RNA expression will be evaluated on sc/snRNA-sequencing technologies
|
Time of surgery
|
|
Gut microbiota
時間枠：Time of surgery
|
Compare stool-based analysis of microbiota between the three patient groups (control, 1.5MIU, 2.0MIU)
|
Time of surgery
|
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Safety and tolerability of IL-2 in patients after acute MI undergoing CABG
時間枠：Time of surgery
|
Safety and tolerability will be assessed by recording adverse events (AEs) and reviewing patient notes.
|
Time of surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月31日
一次修了 (推定)
2028年11月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月20日
最終確認日
2026年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。