Actively Recruiting
Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children
Led by Guangzhou Women and Children's Medical Center · Updated on 2025-04-01
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective, open, single-arm clinical trial was to evaluate the safety and potential efficacy of CAR T cell therapy in children with refractory/recurrent lupus nephritis. The persistence and cell phenotype of CAR-T cells in vivo and CAR-T treatment-related inflammatory factors were evaluated after treatment. To explore new therapeutic methods, in order to reduce the side effects of traditional therapeutic drugs, increase curative effect, and finally make patients obtain long-term survival and improve survival quality.
CONDITIONS
Official Title
Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 18 years old (inclusive)
- Diagnosed with systemic lupus erythematosus (SLE) according to 2019 EULAR/ACR criteria
- Diagnosed with active Class III or IV lupus nephritis, with or without a membranous component, confirmed by biopsy within 6 months before screening
- SLEDAI-2000 score of 8 points or higher
- Refractory lupus nephritis defined as treatment with two or more immunosuppressants for more than 6 months without remission or relapse after remission, accompanied by persistent proteinuria
- Positive CD19 expression in peripheral blood B cells by flow cytometry
- Good venous access and no contraindications for cell collection
- Signed informed consent and voluntary participation
- Basically normal important organ functions, including specified blood counts, liver, kidney, coagulation, and heart functions
- Anti-nuclear antibody (ANA) titer of 1:80 or higher
- Eastern Cooperative Oncology Group (ECOG) physical status score between 0 and 2
You will not qualify if you...
- Previous kidney transplant
- History of serious drug allergies or allergies
- Uncontrolled or treatable fungal, bacterial, viral, or other infections
- Severe dysfunction of heart, liver, lung, or coagulation systems
- Congenital immunoglobulin deficiency
- Infectious diseases including positive hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Diagnosis of malignant tumors in the past five years
- Severe central nervous system disease, mental illness, or severe cognitive dysfunction
- Participation in other clinical trials within 3 months before enrollment
- Previous CAR-T therapy
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xia Gao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here