Actively Recruiting
Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease
Led by Tongji Hospital · Updated on 2024-07-11
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Shenzhen Pregene Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Lupus Nephritis and IgG4-Related Disease.
CONDITIONS
Official Title
Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- If kidneys are involved, estimated glomerular filtration rate (eGFR) is at least 15 mL/min/1.73 m2
- Laboratory tests within 3 days before cell collection meet specified standards for lymphocytes, neutrophils, platelets, hemoglobin, creatinine clearance, bilirubin, and coagulation parameters
- Willingness to sign informed consent
- Fertile men and women agree to use effective contraception from consent signing through 1 year after treatment
- Patients or guardians agree to participate and understand study procedures
- For refractory lupus nephritis: diagnosis per 2019 ACR criteria, active lupus nephritis confirmed by biopsy within 6 months, ineffective or relapsed after standard treatment, positive ANA and/or anti-dsDNA antibodies, and SLE Disease Activity Index score of at least 8 (or clinical score at least 6 with low complement or positive anti-dsDNA)
- For refractory IgG4-related disease: diagnosis per 2019 ACR/EULAR criteria, recurrent or refractory disease, IgG4-RD response index at least 2 indicating active disease, and meeting Mikulitz/systemic clinical phenotype
You will not qualify if you...
- Pregnant or lactating women
- History of malignant tumors within 5 years except certain treated cancers without recurrence
- Received B-cell depletion biologic therapy within 6 months prior to CAR-T reinfusion unless B-cell recovery confirmed
- Received immunosuppressant therapy or systemic corticosteroids over 10 mg/day prednisone equivalent within 3 days prior to CAR-T reinfusion
- Received live vaccine or live therapeutic STD treatment within 2 weeks prior to screening
- Active infections including chronic hepatitis B or C, HIV, or syphilis
- Active infection requiring IV antibiotics or hospitalization
- Significant cardiovascular disease including high NT proBNP, class IV heart failure, recent unstable angina, myocardial infarction, recent stent placement, or coronary artery bypass within 6 months
- Known allergy or severe reaction to study drugs or components
- Other conditions deemed unsuitable by investigator for lymphocyte clearance, cell infusion, or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Lingli Dong
CONTACT
Z
Ziwei Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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