Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

NCT06971913 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SLE-CMV-IL2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SLE (Systemic Lupus); CMV

Outcome Measures

Primary Outcomes (1)

• Changes of NK cell levels

  Changes of absolute NK cell count and NK%.

  Baseline and week 12

Secondary Outcomes (5)

• Duration of CMV viremia

  From enrollment to the end of treatment

• Change of CMV titers

  From enrollment to the end of treatment

• Immune responses

  Baseline and Week 12

• • Complements levels

  Baseline and week 12

• Adverse events (AEs)

  Baseline and week 12

Study Arms (2)

IL-2 group

EXPERIMENTAL

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

OTHER

Control group will be treated with ganciclovir until negative test for CMV DNA load

Drug: Ganciclovir (GCV)

Interventions

Interleukin-2 (IL-2) DRUG

Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity.

IL-2 group

Ganciclovir (GCV) DRUG

Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.

Control group; IL-2 group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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));
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Bejing, 100044, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Interleukin-2; Ganciclovir

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jing He

CONTACT

818611707347; hejing1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: May 14, 2025
• Study Start: May 20, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)