SLE (Systemic Lupus)Phase 2NCT06971913
Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia
A Phase 2 study testing Interleukin-2 (IL-2) and Ganciclovir (GCV) in people with SLE (Systemic Lupus) and CMV, run by Peking University People's Hospital at 1 site in China.
Trial summary
This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SLE (Systemic Lupus), CMV
- What is being tested?
- Interleukin-2 (IL-2) and Ganciclovir (GCV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Dec 2025
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the American College of Rheumatology criteria for the diagnosis of SLE.
- The test for plasma CMV DNA viral load is positive.
- Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.
- Apply corticosteroid less than 1.0mg/kg/d.
- Written informed consent form.
Who cannot join
- Inability to comply with IL-2 treatment regimen;
- Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)
- Any anti-CMV vaccine within 6 months;
- History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;
- Active severe neuropsychiatric manifestations of SLE;
- Severe chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N));
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- Severe complications. (respiratory failure, heart failure or toxic shock)
- Complicated with other autoimmune diseases;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- Pregnancy or lactation in females.
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- Participate in other clinical trial within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Bejing, 100044
Jing He, +8618611707347, hejing1105@126.com
About this study
This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs, and infection is the leading cause of death in SLE. SLE patients are prone to opportunistic infections such as CMV viremia due to treatments with glucocorticoids and immunosuppressives. CMV viremia is a life-threatening complication in the immunocompromised population, which could establish a state of long-term latency following infection. Once CMV is reactivated in hosts, the immune system would be attacked, resulting in exacerbating SLE disease condition.
While traditional available therapies for SLE patients with CMV viremia, to a certain extent, have improved the outcome of these patients, there remains many patients who are antiviral drug-resistant or nonresponsive in clinical practice. Thus, there is an unmet need for safe and more effective treatments. In preliminary clinical trials, we have demonstrated low-dose IL-2 is safe and efficient in autoimmune diseases, including rheumatoid arthritis and SLE. In addition, in spite of sacrificing anti-infection immune function as most immunosuppressive drugs, low-dose IL-2 therapy lowered incidence of infections by upregulating the level of natural killer (NK) cells in SLE patients. In addition, low-dose IL-2 therapy is much less economically burdensome than intravenous immunoglobulin. We hypothesized that low-dose IL-2 could be a novel therapy in SLE patients with CMV viremia.
This is a multicenter, prospective and controlled study to evaluate the efficacy/safety of low-dose IL-2 plus ganciclovir in SLE with active CMV infection.
Methods: SLE patients with CMV viremia will be enrolled and randomly assigned (1:1 ratio) to two groups, low-dose IL-2 group or control group in this study. IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir. Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity. Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day. Control group are going to be treated with ganciclovir. Weekly follow-ups visits will be conducted until participants became CMV negative, the criteria for withdrawing from the trial. The endpoints were changes in NK cells, duration of CMV viremia, clinical, immunologic responses and safety.
- Conditions
- SLE (Systemic Lupus), CMV
- Being tested
- Interleukin-2 (IL-2), Ganciclovir (GCV)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 (IL-2)Drug
Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity.
Ganciclovir (GCV)Drug
Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.
| Study group | Role | What they receive |
|---|---|---|
| IL-2 group | Experimental | IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir. Receives: Drug: Interleukin-2 (IL-2); Drug: Ganciclovir (GCV) |
| Control group | Other | Control group will be treated with ganciclovir until negative test for CMV DNA load Receives: Drug: Ganciclovir (GCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of NK cell levels
Changes of absolute NK cell count and NK%.
Measured: Baseline and week 12
Secondary outcomes (5)
Duration of CMV viremia
Duration of CMV viremia is defined as the time interval between detection of positive CMV DNA load in plasma and CMV negativity.
Measured: From enrollment to the end of treatment
Change of CMV titers
The change (decline) of CMV titers from baseline
Measured: From enrollment to the end of treatment
Immune responses
Changes of levels of immunoglobulins and lymphocyte subtypes, including T/B lymphocytes, Treg, Th1/2/17.
Measured: Baseline and Week 12
• Complements levels
Changes of levels of complement 3/4 (C3/C4)
Measured: Baseline and week 12
Adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start20 May 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971913
- Sponsor's protocol ID
- SLE-CMV-IL2
- Status last verified
- May 2025
- First submitted
- 18 Feb 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia
- ClinicalTrials.gov ID
- NCT06971913
- Acronym / sponsor ID
- SLE-CMV-IL2
- Conditions
- SLE (Systemic Lupus), CMV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 May 2025 (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.
This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs, and infection is the leading cause of death in SLE. SLE patients are prone to opportunistic infections such as CMV viremia due to treatments with glucocorticoids and immunosuppressives. CMV viremia is a life-threatening complication in the immunocompromised population, which could establish a state of long-term latency following infection. Once CMV is reactivated in hosts, the immune system would be attacked, resulting in exacerbating SLE disease condition.
While traditional available therapies for SLE patients with CMV viremia, to a certain extent, have improved the outcome of these patients, there remains many patients who are antiviral drug-resistant or nonresponsive in clinical practice. Thus, there is an unmet need for safe and more effective treatments. In preliminary clinical trials, we have demonstrated low-dose IL-2 is safe and efficient in autoimmune diseases, including rheumatoid arthritis and SLE. In addition, in spite of sacrificing anti-infection immune function as most immunosuppressive drugs, low-dose IL-2 therapy lowered incidence of infections by upregulating the level of natural killer (NK) cells in SLE patients. In addition, low-dose IL-2 therapy is much less economically burdensome than intravenous immunoglobulin. We hypothesized that low-dose IL-2 could be a novel therapy in SLE patients with CMV viremia.
This is a multicenter, prospective and controlled study to evaluate the efficacy/safety of low-dose IL-2 plus ganciclovir in SLE with active CMV infection.
Methods: SLE patients with CMV viremia will be enrolled and randomly assigned (1:1 ratio) to two groups, low-dose IL-2 group or control group in this study. IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir. Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity. Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day. Control group are going to be treated with ganciclovir. Weekly follow-ups visits will be conducted until participants became CMV negative, the criteria for withdrawing from the trial. The endpoints were changes in NK cells, duration of CMV viremia, clinical, immunologic responses and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-2 group | Experimental | Drug: Interleukin-2 (IL-2), Drug: Ganciclovir (GCV)IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir. |
| Control group | Other | Drug: Ganciclovir (GCV)Control group will be treated with ganciclovir until negative test for CMV DNA load |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the American College of Rheumatology criteria for the diagnosis of SLE.
- The test for plasma CMV DNA viral load is positive.
- Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.
- Apply corticosteroid less than 1.0mg/kg/d.
- Written informed consent form.
Key exclusion criteria (12 listed)
- Inability to comply with IL-2 treatment regimen;
- Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)
- Any anti-CMV vaccine within 6 months;
- History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;
- Active severe neuropsychiatric manifestations of SLE;
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)Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity. | Drug | IL-2 group |
| Ganciclovir (GCV)Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day. | Drug | Control group, IL-2 group |
Primary outcome
Changes of NK cell levels
Time frame: Baseline and week 12
Changes of absolute NK cell count and NK%.
5 secondary outcomes
Duration of CMV viremia
Time frame: From enrollment to the end of treatment
Change of CMV titers
Time frame: From enrollment to the end of treatment
Immune responses
Time frame: Baseline and Week 12
• Complements levels
Time frame: Baseline and week 12
Adverse events (AEs)
Time frame: Baseline and week 12
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 14 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-2 (IL-2) and Ganciclovir (GCV) in people with SLE (Systemic Lupus) and CMV, run by Peking University People's Hospital at 1 site in China.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 14 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jing He (818611707347, hejing1105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of NK cell levels (time frame: Baseline and week 12). 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 14 May 2025.