Actively Recruiting
Safety and Efficacy of PRG-2311 (CD19/BCMA-targeting CAR-T Cells) for Refractory Lupus Nephritis and IgG4-Related Disease
Led by Tongji Hospital · Updated on 2024-07-11
30
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of PRG-2311, a type of CD19/BCMA-targeting CAR-T cell therapy, for treating people with refractory lupus nephritis and IgG4-related disease. This early phase 1 clinical trial aims to find a safe and effective dose of this new cell therapy for patients who have not responded to standard treatments. The study is sponsored by Tongji Hospital and focuses on these serious immune-related kidney and systemic conditions. The trial has two main parts: a dose exploration phase and a dose expansion phase. In the dose exploration phase, participants receive one of three different doses of PRG-2311 to evaluate safety and dose-limiting toxicities. If the dose is found to be safe and effective, the dose expansion phase includes more patients receiving that dose to further assess its safety and effectiveness for lupus nephritis and IgG4-related disease separately. Participants will be closely monitored for up to 24 months after receiving the PRG-2311 infusion. Researchers will measure safety outcomes such as adverse events and dose tolerance, and track changes in disease activity scores, kidney function, relapse rates, and immune system markers. Laboratory tests, blood samples, and patient questionnaires will be collected at multiple timepoints to understand how the treatment affects the diseases and the immune system over time.
CONDITIONS
Brief 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) must be at least 15 mL/minute/1.73 m2
- Specific blood test values within 3 days before mononuclear cell collection, including minimum counts for lymphocytes, neutrophils, platelets, and hemoglobin
- Creatinine clearance rate or glomerular filtration rate (Cockcroft Gault formula) of at least 30 mL/min
- Total bilirubin serum level within 1.5 times the upper limit of normal (ULN), with exceptions for Gilbert syndrome
- Liver enzymes AST and ALT within 3 times ULN
- Blood clotting times (PT, INR, APTT) within 1.5 times ULN
- Willingness to sign informed consent and use effective contraception if of childbearing age
- Diagnosis of refractory lupus nephritis confirmed by biopsy and disease activity scores, or diagnosis of active refractory IgG4-related disease meeting established criteria
- Positive autoantibodies (ANA and/or anti-dsDNA) for lupus nephritis
You will not qualify if you...
- Pregnant or breastfeeding women
- History of malignant tumors within 5 years with some exceptions
- Received B-cell depletion biologic therapy within 6 months prior to CAR-T reinfusion unless B-cell recovery is documented
- Immunosuppressant or systemic corticosteroid therapy 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 hepatitis B, C, HIV, or syphilis
- Active infection requiring intravenous antibiotics or hospitalization
- Significant cardiovascular disease including heart failure grade IV or recent heart interventions
- Known allergy or severe reaction to study drugs or components
- Any other conditions making the participant unsuitable for lymphocyte clearance, cell infusion, or study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with follow-up up to 24 months
Participants receive PRG-2311 (CD19/BCMA-targeting CAR-T Cells) infusion following dose exploration and dose expansion phases to evaluate safety and efficacy.
Multiple visits around infusion and frequent visits during initial weeks for monitoring
Duration - Up to 24 months after infusion
Participants are monitored for safety, efficacy, and pharmacokinetics up to 24 months after infusion with assessments of disease activity and laboratory evaluations.
Visits at Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, and monthly up to 24 months
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Lingli Dong
Z
Ziwei Hu
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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