Actively Recruiting
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Children With Refractory Refractory AAV
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-12-02
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor
C
Children's Hospital of Chongqing Medical University
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 refractory ANCA-Associated Vasculitis.
CONDITIONS
Official Title
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Children With Refractory Refractory AAV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 25 years old
- Diagnosed with AAV by 2022 EULAR/ACR criteria and refractory to glucocorticoids, cyclophosphamide, and rituximab for at least 3 months or relapsed after remission
- Or treated with glucocorticoid plus immunosuppressants for 3 months but failed sustained remission or relapsed
- Or diagnosed with severe vasculitis unresponsive to routine treatment and considered suitable by investigator
- For patients under 18 years old: PVAS score 15 or higher; for 18 years and older: BVAS score 15 or higher
- Normal important organ functions: LVEF ≥55%, normal ECG, eGFR ≥30 mL/min/1.73m2, AST and ALT ≤3 times upper limit, TBIL ≤2 times upper limit, SpO2 ≥92%
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test for females of childbearing age and agreement to use contraception for one year after treatment
- Signed informed consent by participant or guardian
You will not qualify if you...
- Previous CAR-T cell therapy
- Central nervous system disease requiring intervention within 60 days
- Pulmonary hemorrhage requiring ventilation support for over 1 week
- History of congenital heart disease or recent myocardial infarction within 6 months; severe arrhythmias or serious myocarditis
- Need for long-term glucocorticoid or high-dose immunosuppressive treatment for other diseases
- Uncontrolled or active infection requiring treatment within 1 week
- History of organ or stem cell transplantation or Grade 2 or higher GVHD within 2 weeks
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- Live vaccine received within 4 weeks
- Positive pregnancy test
- Current or past cancer
- Participation in other clinical studies within 3 months
- Any other condition judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jianhua Mao, PhD
CONTACT
J
Junyi Chen, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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