Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells (Leuk-ALIVE)
2026년 5월 20일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
24
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 0QQ
- 모병
- Addenbrooke's Hospital
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연락하다:
- Ali Al-Hadithi, MB BChir
- 전화번호: 01223768678
- 이메일: abaka2@cam.ac.uk
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Cambridge, Cambridgeshire, 영국, CB2 0AY
- 모병
- Royal Papworth Hospital NHS Foundation Trust
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연락하다:
- Ali Al-Hadithi, MB BChir
- 전화번호: 01223768678 Royal Papworth Hospital NHS Fo
- 이메일: abaka2@cam.ac.uk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 제어
치료 기준
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Standard care for patients with coronary artery disease undergoing CABG surgery
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실험적: 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
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5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
다른 이름들:
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
다른 이름들:
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실험적: 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
다른 이름들:
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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Compare the differences in tissue-resident Treg gene signature in patients treated with ld-IL-2 compared to control
기간: 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
기간: 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.
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Time of surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in inflammatory T effector cells
기간: Time of surgery
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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)
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Time of surgery
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Difference in other immune cells
기간: Time of surgery
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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)
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Time of surgery
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Comparing T cell receptor repertoire
기간: 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)
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Time of surgery
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Comparing tissue-resident immune cells to circulating immune cells
기간: Time of surgery
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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.
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Time of surgery
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Systemc biomarkers of inflammation and tissue damage
기간: Time of surgery
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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
기간: 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
기간: 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
기간: 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
기간: Time of surgery
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Safety and tolerability will be assessed by recording adverse events (AEs) and reviewing patient notes.
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Time of surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 31일
기본 완료 (추정된)
2028년 11월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 20일
QC 기준을 충족하는 최초 제출
2026년 5월 20일
처음 게시됨 (실제)
2026년 5월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 20일
마지막으로 확인됨
2026년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A097309
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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