The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.

NCT05975554 | Active Not Recruiting

• 1 other identifier: A096090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trail is to compare the differences in carotid plaque Treg cells' gene signature for activation, proliferation, and suppressive function using scRNA-seq in patients treated with IL-2 compared to control.

Conditions

TIA; Carotid Artery Plaque; Carotid Atherosclerosis

Keywords

Interleukin-2; IL-2; TIA; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Difference in gene expression in Tregs

  Comparing differential gene expression using scRNA-seq technologies, from isolated Tregs from carotid plaques from the two patient groups (IL-2 treatment and control). Differential gene expression will be assessed using standard techniques (Z-Score)

  Time of surgery

Secondary Outcomes (3)

• Difference in gene expression in Teff cells.

  Time of surgery

• Immune cell gene signature, in plaque and blood.

  Time of surgery

• Difference in gene expression patterns in Treg & Teff cells.

  Baseline and at time of surgery

Other Outcomes (4)

• Other immune cell and vascular smooth muscle cell gene expression

  Time of surgery

• Ligand-receptor interactions.

  Time of surgery

• T-Cell receptor profile

  Time of surgery

Study Arms (2)

Low dose interleukin-2

EXPERIMENTAL

Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC.

Drug: Interleukin-2 [IL-2]; Procedure: Standard care - Carotid Endarterectomy

Control

ACTIVE COMPARATOR

Standard of care treatment

Procedure: Standard care - Carotid Endarterectomy

Interventions

Interleukin-2 [IL-2] DRUG

5 sequential days of treatment (1.5MIU/day subcutaneously)

Low dose interleukin-2

Standard care - Carotid Endarterectomy PROCEDURE

Standard care for patients with carotid stenosis undergoing carotid endarterectomy

Control; Low dose interleukin-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of carotid stenosis on either ultrasound or CT scan.
• Planned to undergo carotid endarterectomy.

You may not qualify if:

• Autoimmune disease
• Any regular immunosuppressive treatment \[Inhaled or topical steroids are permissible\]
• Modified Rankin Scale score of ≥4 at screening
• Known active hepatic disease or alanine aminotransferase (ALT) \> 2xULN
• Severe chronic kidney disease (defined as eGFR \< 30 ml/min/1.73m2)
• Allergy or intolerance to aldesleukin
• Signs or 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 or plans for vaccination during study period
• Women of child-bearing potential and pregnancy
• Women who are breast-feeding
• Clinically relevant medical or surgical conditions that, in the opinion of the

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Analysis blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BHF Clinical Lecturer in Cardiovascular Medicine.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 4, 2023
• Study Start: August 26, 2023
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

GB (1)