Actively Recruiting
Clinical Study of CD19 CAR-T in the Treatment of Refractory Systemic Sclerosis
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-12-22
12
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
Sponsors
T
The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor
G
Guangzhou Women and Children's Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset systemic sclerosis
CONDITIONS
Official Title
Clinical Study of CD19 CAR-T in the Treatment of Refractory Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender, aged 5 years or older
- Meets 2013 ACR/EULAR criteria for systemic sclerosis diagnosis
- Positive for anti-nuclear antibodies or systemic sclerosis-specific antibodies
- Modified Rodnan skin score of 15 points or higher
- Has refractory disease with no significant improvement after at least 3 months of glucocorticoids and immunomodulators or rapid disease progression with ineffective routine treatment
- Major organ functions are basically normal, including LVEF ≥ 55%, normal ECG, eGFR ≥ 30 mL/min/1.73m2, AST and ALT ≤ 3 times upper limit, total bilirubin ≤ 2 times upper limit, SpO2 ≥ 92%, DLCO ≥ 40%, FVC ≥ 50%
- Negative urine pregnancy test if of childbearing potential and agrees to use effective contraception during study and for 1 year after infusion
- Provides informed consent with understanding of study purpose and procedures
You will not qualify if you...
- Severe pulmonary hypertension (mean pulmonary pressure > 45 mmHg) or other severe major organ involvement
- Previous CAR-T cell therapy unless safety risks are ruled out
- Active central nervous system diseases such as epilepsy, stroke, dementia, or cerebellar disorders
- Congenital heart disease, recent myocardial infarction within 6 months, severe arrhythmias, large pericardial effusion, serious myocarditis, or unstable vital signs needing vasoactive drugs
- Active tuberculosis or uncontrolled infections requiring systemic treatment
- Received organ or stem cell transplant within 3 months or recent acute graft-versus-host disease grade 2 or higher
- Positive for hepatitis B or C virus with abnormal viral load, HIV antibodies, or syphilis antibodies
- Received live vaccine within 4 weeks before screening
- Positive blood pregnancy test
- Known malignant tumors
- Participated in other interventional trials within 3 months
- Any other condition deemed inappropriate for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 0571
Actively Recruiting
2
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, Christmas Island, 310053
Actively Recruiting
Research Team
J
Jianhua Mao Children's Hospital, Zhejiang University School of Medicine, PHD
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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