A Phase 2 interventional study of Interleukin-2 (IL-2) and Ganciclovir (GCV) in SLE (Systemic Lupus) and CMV, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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Among 10 studies testing Interleukin-2 in Lupus Erythematosus, Systemic — 3 open to participants now, 3 under way, 2 of them phase 3. Interleukin-2 · Lupus Erythematosus, Systemic.
Among the 10 studies testing Interleukin-2 in Lupus Erythematosus, Systemic, this one is the 2nd largest by planned enrollment, is the only one that started in 2025, is one of 4 in phase 2, and was the 10th registered.
1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →3 of the 10 studies testing Interleukin-2 in Lupus Erythematosus, Systemic are open now, in 1 country. Recruiting first, the newest first:
Liu Tian · Sites in China
Ages 18–65
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Sites in China
Ages 18–65
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 52 across 878 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 53 across the 10 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 5 most frequent:
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
Peking University People's Hospital has 9 studies filed under Lupus Erythematosus, Systemic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing Interleukin-2 in Lupus Erythematosus, Systemic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir.
Drug: Interleukin-2 (IL-2) · Drug: Ganciclovir (GCV)
Control group will be treated with ganciclovir until negative test for CMV DNA load
Drug: Ganciclovir (GCV)
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.
Changes of NK cell levels
Changes of absolute NK cell count and NK%.
Time frame: Baseline and week 12
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.
Time frame: From enrollment to the end of treatment
Change of CMV titers
The change (decline) of CMV titers from baseline
Time frame: 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.
Time frame: Baseline and Week 12
• Complements levels
Changes of levels of complement 3/4 (C3/C4)
Time frame: Baseline and week 12
Adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events.
Time frame: Baseline and week 12
Start is estimated for May 2025; primary completion for Sep 2025, 4 months later.
Of 95 phase 2 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 56. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin-2
Lupus Erythematosus, Systemic →
Peking University People's Hospital →