Actively Recruiting
Safety and Efficacy of PRG-1801 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 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-1801 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 involved, estimated glomerular filtration rate (eGFR) at least 15 mL/min/1.73 m2
- Absolute lymphocyte count at least 0.5 × 10^9/L without granulocyte colony-stimulating factor (G-CSF) within 7 days prior to screening
- Absolute neutrophil count at least 1.0 × 10^9/L without G-CSF within 7 days prior to screening
- Platelet count at least 50 × 10^9/L without blood transfusion within 7 days prior to screening
- Hemoglobin at least 8.0 g/dL without red blood cell transfusion within 7 days prior to screening
- Creatinine clearance rate or glomerular filtration rate at least 30 mL/min
- Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN); exceptions with consent
- Prothrombin time, activated partial thromboplastin time, and INR all less than or equal to 1.5 times ULN
- Willingness to sign informed consent
- Fertile men and women of childbearing potential agree to use effective contraception from consent through 1 year after treatment; negative pregnancy tests at screening and before infusion
- For refractory lupus nephritis: diagnosis confirmed by biopsy within 6 months, positive ANA and/or anti-dsDNA antibodies, SLEDAI-2000 score at least 8 (clinical score at least 6 with low complement or anti-dsDNA positivity)
- For refractory IgG4-related disease: diagnosis per 2019 ACR/EULAR criteria, recurrent or refractory disease, active stage with IgG4-RD response index at least 2, and clinical phenotype of Mikulitz/systemic
You will not qualify if you...
- Pregnant or breastfeeding women
- History of malignant tumors within 5 years, except for specific treated cancers without recurrence as defined
- Received any B-cell depletion biologic therapy within 6 months prior to CAR-T reinfusion without B-cell recovery
- Received immunosuppressants or systemic corticosteroids over 10 mg/day prednisone or equivalent within 3 days prior to CAR-T reinfusion
- Received live vaccines or live therapeutic STD treatments within 2 weeks prior to screening
- Active chronic infections including hepatitis B (except low HBV DNA), hepatitis C, HIV, or syphilis
- Active infection requiring intravenous antibiotics or hospitalization
- Significant cardiovascular disease including high NT proBNP, severe heart failure, recent unstable angina or myocardial infarction, recent cardiac interventions within 6 months
- Known allergies or severe reactions to study components or related drugs
- Other conditions judged by investigators as unsuitable 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, MD
CONTACT
Z
Ziwei Hu, MD
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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