Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

NCT06789107 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BRASLE
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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. 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? 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

Outcome Measures

Primary Outcomes (1)

• safety of Blinatumomab

  Safety and tolerability: type, frequency and severity of adverse events

  with 12 weeks of Blinatumomab treatment

Secondary Outcomes (3)

• Proportion of patients achieving DORIS remission after treatment of Blinatumomab

  with 24 weeks of Blinatumomab

• Proportion of patients achieving SRI-4 remission after treatment of Blinatumomab

  12 weeks and 24 weeks

• Changes in peripheral blood CD19+ B cells

  within 52 weeks

Study Arms (1)

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.

Drug: Blinatumomab 9ug

Interventions

Blinatumomab 9ug DRUG

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.

Experimental: Blinatumomab Treatment

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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;

You may not qualify 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, 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;
• 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;

Sponsors & Collaborators

• Mao Jianhua: lead

Study Sites (2)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310051, China

RECRUITING

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

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

Study Officials

• Jianhua Mao, PhD, MD

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Mao, PhD, MD

CONTACT

13516819071; maojh88@zju.edu.cn

Xiaojing Zhang, MD

CONTACT

15867172808; 6510007@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 23, 2025
• Study Start: December 8, 2024
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): December 7, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-09

Locations

CN (2)