Actively Recruiting
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
18
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).
CONDITIONS
Official Title
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 3-65 years
- Diagnosed with SLE meeting 2019 EULAR/ACR classification criteria
- Positive antinuclear antibody (ANA) test or positive anti-dsDNA serum antibody test
- Refractory SLE with prednisolone use or disease relapse after standard treatment
- Refractory lupus nephritis confirmed by biopsy within 6 months before screening
- CD19+ on B cells and able to stop immunosuppressive drugs for more than 1 week
- Blood lymphocyte count greater than 1 x 10^9/L without contraindications for cell collection
- No severe allergy
- ECOG performance status score from 0 to 2
- Expected survival of at least 90 days
- Participant or guardian understands and signs informed consent
You will not qualify if you...
- Impaired consciousness or intracranial hypertension above 15 mmHg
- Severe cardiac conditions including heart failure, arrhythmia, or myocardial infarction within 6 months
- Severe respiratory failure or pulmonary hypertension
- Other active lung diseases unrelated to SLE
- Presence of other malignancies
- Disseminated intravascular coagulation (DIC)
- Active uncontrolled infections excluding fungal nail infection
- Uncontrolled diabetes with elevated blood glucose or complications
- Serious mental illness impairing treatment or consent
- Active intracranial lesions on MRI
- Previous organ transplantation except stem cell transplant
- Pregnancy or breastfeeding
- Positive tests for hepatitis, AIDS, or syphilis
- No blood cell collection available for CAR T cell manufacturing
- Severe kidney impairment (eGFR less than 30 ml/min/1.73m2)
- Inability to discontinue immunosuppressive agents for 7 days or recurrence during discontinuation
- Active skin diseases interfering with SLE evaluation including psoriasis and dermatomyositis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
T
Tengyu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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