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Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

NCT06789107 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

DRUG

Blinatumomab 9ug

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.

Sponsors & Collaborators

  • Mao Jianhua

    lead OTHER

Principal Investigators

  • Jianhua Mao, PhD, MD · Children's Hospital, Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-08
Primary Completion
2027-12-07
Completion
2027-12-07
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789107 on ClinicalTrials.gov