Actively Recruiting
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Led by He Huang · Updated on 2025-01-21
9
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
H
He Huang
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
CONDITIONS
Official Title
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of systemic lupus erythematosus (SLE) with biopsy-confirmed grade III, IV, or V lupus nephritis
- SLEDAI-2K score of 8 or higher during screening
- Failure to respond to two or more standard immunosuppressive therapies or experienced a relapse
- Expected survival longer than 12 weeks
- Fertile women and men agree to use contraception before, during, and for 6 months after treatment
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of brain trauma, unconsciousness, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Prolonged QT interval on ECG or severe heart diseases such as serious arrhythmias
- Active untreated infections
- Active hepatitis B or C virus infection
- Use of more than 20mg per day prednisone or equivalent systemic steroids within 1 week before treatment (except inhaled steroids)
- Previous use of any gene therapy products
- Insufficient cell response to CD3/CD28 stimulation
- ALT or AST levels more than 3 times normal or bilirubin above 2.0 mg/dl
- Other uncontrolled diseases deemed unsuitable by the researcher
- HIV infection
- Any condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
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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