Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorMao Jianhua

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥ 5 years old.

Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.

Antinuclear antibody (ANA) ≥ 1:80.

Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Experimental: Blinatumomab TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

safety of Blinatumomab

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

Time frame
with 12 weeks of Blinatumomab treatment

Secondary outcomes

1

Proportion of patients achieving DORIS remission after treatment of Blinatumomab

DORIS response rate

Time frame
with 24 weeks of Blinatumomab
2

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

SRI-4 response rate

Time frame
12 weeks and 24 weeks
3

Changes in peripheral blood CD19+ B cells

B cell clearance at each time point

Time frame
within 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mao Jianhua

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Sponsor institution