Systemic Lupus Erythematosus (SLE)Phase 1BRASLENCT06789107
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
A Phase 1 study testing Blinatumomab 9ug in people with Systemic Lupus Erythematosus (SLE) and Children, run by Mao Jianhua at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Children, Blinatumomab
- What is being tested?
- Blinatumomab 9ug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 8 Dec 2024to 7 Dec 2027
- Phase
- Phase 1
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to 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).
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- 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.
Who cannot join
- 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 high-dose glucocorticoid (prednisone dose ≥ 2 mg/kg/d or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;
- 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 with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs, patients who need blood pressure-raising drugs to maintain blood pressure;
- Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;
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- 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 screening;
- 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 (detectable HCV ribonucleic acid [RNA]). Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection;
- A history of tuberculosis or active tuberculosis; or latent tuberculosis treated before the baseline; or subjects with an indeterminate test result who screened positive for PPD or T-spot can be retested, but if the repeat test is also indeterminate, they are excluded;
- 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 screening;
- 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, Secukinumab, or Atacicept;
- 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 injection;
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310051
Jianhua Mao, PhD, MD, 86+13616819071, maojh88@zju.edu.cn
Xiaojing Zhang, MD, 15867172808, 6510007@zju.edu.cn
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jianhua Mao, MD, 13616819071, maojh88@zju.edu.cn
Xiaojing Zhang, MD, 15867172808, 6510007@zju.edu.cn
About this study
Official title: Clinical Trial of Blinatumomab in Refractory/Active Systemic Lupus Erythematosus in Children
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. The main questions it aims to answer are:
Does blinatumomab improve symptoms and disease activity in refractory/active SLE? What side effects or adverse events do participants experience when taking blinatumomab?
Read more
Participants will:
Receive two courses of blinatumomab injections over five consecutive days each Be monitored for 52 weeks to evaluate the treatment's safety and effectiveness Undergo regular blood tests and assessments of disease activity during follow-up visits Researchers will collect data on changes in serological markers, disease symptoms, and adverse events throughout the study.
- Conditions
- Systemic Lupus Erythematosus (SLE), Children, Blinatumomab
- Being tested
- Blinatumomab 9ug
- 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.
Blinatumomab 9ugDrug
Blinatumomab for Refractory/Active Systemic Lupus Erythematosus. Patients will receive two 5-day cycles of Blinatumomab (5 µg/m²/day, maximum dose 9 µg/day), administered intravenously. The second cycle will begin on the first day of the third week following the first cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Blinatumomab Treatment | Experimental | Blinatumomab treatment for Refractory/Active Systemic Lupus Erythematosus. Patients will receive two 5-day cycles of Blinatumomab (5 µg/m²/day, maximum dose 9 µg/day), administered intravenously. The second cycle will begin on the first day of the third week following the first cycle. Receives: Drug: Blinatumomab 9ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of Blinatumomab
Safety and tolerability: type, frequency and severity of adverse events
Measured: with 12 weeks of Blinatumomab treatment
Secondary outcomes (3)
Proportion of patients achieving DORIS remission after treatment of Blinatumomab
DORIS response rate
Measured: with 24 weeks of Blinatumomab
Proportion of patients achieving SRI-4 remission after treatment of Blinatumomab
SRI-4 response rate
Measured: 12 weeks and 24 weeks
Changes in peripheral blood CD19+ B cells
B cell clearance at each time point
Measured: within 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start8 Dec 2024
- Primary completion7 Dec 2027 (estimated)
- Study completion7 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mao Jianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Jianhua Mao, PhD, MD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789107
- Sponsor's protocol ID
- BRASLE
- Acronym
- BRASLE
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No