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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06789107
What this study is testing
What is Blinatumomab 9ug?
Blinatumomab 9ug is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults. It will also learn about the safety of blinatumomab.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 and older
You may be able to join if
- Participants must meet all the following criteria to be eligible for enrollment:
- Age: ≥ 5 years old.
- Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.
- Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:
- Antinuclear antibody (ANA) ≥ 1:80.
You likely can't join if
- Participants meeting any of the following criteria will be excluded:
- Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion...
- Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the...
- Severe antiphospholipid syndrome within 12 months before or during screening；
- Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic...
- Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;
See the full eligibility criteria
Who can join
- Participants must meet all the following criteria to be eligible for enrollment:
- Age: ≥ 5 years old.
- Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.
- Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:
- Antinuclear antibody (ANA) ≥ 1:80.
- Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).
- Anti-Smith (Anti-Sm) antibody above the ULN.
- Treatment Resistance: Inadequate response to at least three of the following:
- Oral corticosteroids (OCS),
- Antimalarials,
- Conventional immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide),
- Biologics (e.g., TULIP-2, belimumab, rituximab). At least one treatment must involve immunosuppressants or biologics.
- SLEDAI-2000 Score: ≥ 6 based on the SLEDAI-2000 scoring system.
- Stable Standard Treatment: Currently receiving one or more of the following treatments at a stable dose:
- OCS (e.g., prednisone acetate or equivalent) at a stable dose for ≥7 days prior to initiation;
- Antimalarials: Dose stable for at least 7 days prior to the first dose.
- Conventional immunosuppressants: Stable dose for at least 4 weeks before screening and throughout the study.
- Laboratory Parameters:
- Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L.
- Peripheral CD19+ B cell count ≥ 25 cells/μL.
- Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L.
- Hemoglobin ≥ 80 g/L.
- Platelet count ≥ 75 × 10⁹/L \ .
- Left ventricular ejection fraction (LVEF) ≥ 55% with no significant ECG abnormalities.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m².
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin ≤ 2 × ULN.
- No severe pulmonary lesions, SpO₂ ≥ 92%.
- Contraception: Female participants of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study and for 1 year after infusion.
- Informed Consent: The participant and their legal guardian must provide written informed consent, demonstrating understanding of the study objectives and willingness.
- Note: For SLE patients with thrombocytopenia below the inclusion threshold due to immune-related causes, and without active bleeding, investigators may use clinical discretion to determine eligibility.
What rules you out
- Participants meeting any of the following criteria will be excluded:
- Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;
- Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the opinion of the investigator, may occur and lead to the need for...
- Severe antiphospholipid syndrome within 12 months before or during screening；
- Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic ventricular tachycardia, ventricular tachycardia, etc.); or combined...
- Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;
- Having active infections or uncontrollable infections that require systemic treatment within one week before screening;
- Having received solid organ transplantation or hematopoietic stem cell transplantation within three months before screening; or having grade 2 or higher acute graft-versus-host disease (GVHD) within two weeks before...
- History of severe recurrent or chronic infections, especially recurrent or chronic infections associated with respiratory problems.
- Immunoglobulin G levels below the lower limit (5-8 years: \<4.5 g/L, 9 years and older: \<6.0 g/L);
- History of hepatitis B virus (HBV) infection or positive serology indicating current or past HBV infection. Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection...
- A history of tuberculosis or active tuberculosis; or latent tuberculosis treated before the baseline; or people with an indeterminate test result who screened positive for PPD or T-spot can be retested, but if the...
- Had a history of macrophage activation syndrome within 1 month prior to screening;
- Had received any anti-CD19 or anti-CD20 therapy, such as rituximab, obinutuzumab, ocrelizumab, or ofatumumab, within 3 months prior to screening or during screening;
- Received a JAK inhibitor, Bruton tyrosine kinase (BTK) inhibitor, or tyrosine kinase 2 (TYK2) inhibitor, such as baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or zanubrutinib and Fenebrutinib, during...
- Treatment with cyclophosphamide or a biologic agent within 4 weeks prior to enrollment, including but not limited to adalimumab, etanercept, golimumab, infliximab, Infliximab), Belimumab, Ustekinumab, Anifrolumab...
- Intolerance or contraindication to the investigational therapy, including a history of severe allergies or allergic reactions to monoclonal antibodies, or a known hypersensitivity to any of the ingredients in belimumab...
- Live vaccine within 4 weeks prior to screening;
- Positive blood pregnancy test;
- Patients with known malignant diseases such as tumors before screening;
- Patients who have participated in other clinical trials within 3 months prior to enrollment;
- Patients with depression or suicidal tendencies;
- Other situations where the investigator believes the patient is not suitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.