TIAELLIPSENCT05975554
The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.
A study testing Interleukin-2 [IL-2] in people with TIA and Carotid Artery Plaque, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TIA, Carotid Artery Plaque, Carotid Atherosclerosis
- What is being tested?
- Interleukin-2 [IL-2]
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of carotid stenosis on either ultrasound or CT scan.
- Planned to undergo carotid endarterectomy.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
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.
Read the detailed description
Up till now our Lab has looked at Tregs and immune cells in the blood. The question remains whether low dose IL-2 can have the desired effect on Tregs in atherosclerotic plaques where they could alter the pathophysiology and potentially clinical outcomes for patients.
Up until recently, the cellular composition and cell-specific expression patterns of human atherosclerotic plaques remained elusive. However, recent breakthroughs studies using scRNA-seq, CITE-seq, and single-cell ATAC-seq on human carotid plaques have offered important insight into plaque composition, cell heterogeneity, and cell-cell interactions giving new perspectives on mechanisms of disease. The next logical stage is to use this new insight and powerful biological tool to assist in drug development for patients.
Therefore, the aims of the study are:
- To assess if low dose IL-2, given systemically to patients at our proposed dose, can alter Tregs in atherosclerotic plaques (the disease tissue) to exhibit a proliferating, activated, and immunosuppressive phenotype
- To assess if modulating plaque Tregs can cause a shift in the plaque immune landscape to a less inflammatory phenotype
- To study the relationship between plaque and circulating immune cells after systemic immune modulation
- Conditions
- TIA, Carotid Artery Plaque, Carotid Atherosclerosis
- Being tested
- Interleukin-2 [IL-2], Standard care - Carotid Endarterectomy
- Keywords
- Interleukin-2, IL-2, TIA, Carotid Stenosis
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 [IL-2]Drug
5 sequential days of treatment (1.5MIU/day subcutaneously)
Standard care - Carotid EndarterectomyProcedure or surgery
Standard care for patients with carotid stenosis undergoing carotid endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| Low dose interleukin-2 | Experimental | Commercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. Receives: Drug: Interleukin-2 [IL-2]; Procedure: Standard care - Carotid Endarterectomy |
| Control | Active comparator | Standard of care treatment Receives: Procedure: Standard care - Carotid Endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time of surgery
Secondary outcomes (3)
Difference in gene expression in Teff cells.
Comparing differential gene expression using scRNA-seq technologies, from isolated Teffs from carotid plaques from the two patient groups (IL-2 treatment and control). Differential gene expression will be assessed using standard techniques (Z-Score)
Measured: Time of surgery
Immune cell gene signature, in plaque and blood.
Difference in immune cell gene signature will be compared using scRNA-seq in both plaque and blood samples, and further compared between IL-2 and control groups. Comparative analysis will be completed using gene set enrichment analysis (Enrichment Score).
Measured: Time of surgery
Difference in gene expression patterns in Treg & Teff cells.
Comparison between Treg and Teff cells collected at baseline and day of surgery will be compared between IL-2 and control groups. Differential gene expression will be assessed using standard techniques (Z-Score)
Measured: Baseline and at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start26 Aug 2023
- Primary completion1 Feb 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Zhao, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975554
- Sponsor's protocol ID
- A096090
- Acronym
- ELLIPSE
- Status last verified
- May 2025
- First submitted
- 14 Jun 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.
- ClinicalTrials.gov ID
- NCT05975554
- Acronym / sponsor ID
- ELLIPSE / A096090
- Conditions
- TIA, Carotid Artery Plaque, Carotid Atherosclerosis
- Keywords
- Interleukin-2, IL-2, TIA, Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up till now our Lab has looked at Tregs and immune cells in the blood. The question remains whether low dose IL-2 can have the desired effect on Tregs in atherosclerotic plaques where they could alter the pathophysiology and potentially clinical outcomes for patients.
Up until recently, the cellular composition and cell-specific expression patterns of human atherosclerotic plaques remained elusive. However, recent breakthroughs studies using scRNA-seq, CITE-seq, and single-cell ATAC-seq on human carotid plaques have offered important insight into plaque composition, cell heterogeneity, and cell-cell interactions giving new perspectives on mechanisms of disease. The next logical stage is to use this new insight and powerful biological tool to assist in drug development for patients.
Therefore, the aims of the study are:
- To assess if low dose IL-2, given systemically to patients at our proposed dose, can alter Tregs in atherosclerotic plaques (the disease tissue) to exhibit a proliferating, activated, and immunosuppressive phenotype
- To assess if modulating plaque Tregs can cause a shift in the plaque immune landscape to a less inflammatory phenotype
- To study the relationship between plaque and circulating immune cells after systemic immune modulation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose interleukin-2 | Experimental | Drug: Interleukin-2 [IL-2], Procedure: Standard care - Carotid EndarterectomyCommercially available aldesleukin with a UK marketing authorisation will be used and will be initially prepared as per SmPC. |
| Control | Active comparator | Procedure: Standard care - Carotid EndarterectomyStandard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of carotid stenosis on either ultrasound or CT scan.
- Planned to undergo carotid endarterectomy.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin-2 [IL-2]5 sequential days of treatment (1.5MIU/day subcutaneously) | Drug | Low dose interleukin-2 |
| Standard care - Carotid EndarterectomyStandard care for patients with carotid stenosis undergoing carotid endarterectomy | Procedure or surgery | Control, Low dose interleukin-2 |
Primary outcome
Difference in gene expression in Tregs
Time frame: Time of surgery
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)
3 secondary outcomes
Difference in gene expression in Teff cells.
Time frame: Time of surgery
Immune cell gene signature, in plaque and blood.
Time frame: Time of surgery
Difference in gene expression patterns in Treg & Teff cells.
Time frame: Baseline and at time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin-2 [IL-2] in people with TIA and Carotid Artery Plaque, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gene expression in Tregs (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.