Actively Recruiting
Safety and Efficacy of PRG-1801 (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 studying the safety and effectiveness of PRG-1801, a BCMA-targeting CAR-T cell therapy, in treating patients with refractory lupus nephritis and IgG4-related disease. This early-phase clinical trial aims to find a safe and effective dose of PRG-1801 for these difficult-to-treat autoimmune conditions, providing important information on treatment potential and safety. The study includes two phases: a dose exploration phase with three dose levels (35, 100, and 300 million CAR-T cells) where groups of 3 to 6 patients will be treated and monitored for dose-limiting toxicities, and a dose extension phase where the safe and effective dose identified is further tested in additional patients with each disease. The treatment involves an infusion of PRG-1801 cells, followed by close evaluation to determine safety and response. Participants will undergo regular assessments for up to 24 months after receiving the infusion. These include monitoring for adverse events, blood tests to measure immune cell changes and disease activity, and disease-specific evaluations such as the SLE Disease Activity Index for lupus nephritis and relapse rates for IgG4-related disease. Researchers will also track pharmacokinetic and pharmacodynamic markers and use questionnaires to assess quality of life and symptoms throughout the study period.
CONDITIONS
Brief 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 are involved, estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m2 or higher
- Absolute lymphocyte count at least 0.5 x 10^9/L
- Absolute neutrophil count at least 1.0 x 10^9/L
- Platelet count at least 50 x 10^9/L
- Hemoglobin level of at least 8.0 g/dL
- Creatinine clearance rate or glomerular filtration rate (Cockcroft Gault) at least 30 mL/min
- Total serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN); exceptions allowed with sponsor consent
- Plasma prothrombin time (PT), INR, and APTT less than or equal to 1.5 times ULN
- Willingness to sign informed consent
- Fertile men and women agree to use effective contraception from consent signing until 1 year after treatment
- Negative pregnancy test for women of reproductive age at screening and before infusion
- Diagnosis of active, proliferative lupus nephritis (type III, IV, or V) confirmed by biopsy and meeting ACR and ISN/RPS criteria with prior ineffective treatment or relapse
- Positive anti-nuclear antibodies (ANA) and/or anti-dsDNA antibodies
- SLE Disease Activity Index (SLEDAI-2000) score 8 or higher during screening
- Diagnosis of recurrent or refractory IgG4-related disease meeting ACR/EULAR criteria
- IgG4-Related Disease Responder Index (RI) score 2 or higher and active disease status
- Clinical phenotype of Mikulitz/systemic disease
You will not qualify if you...
- Pregnant or breastfeeding women
- History of malignant tumors within 5 years, except certain cases fully treated without recurrence
- Received B-cell depletion biologic therapy within 6 months prior to reinfusion unless B-cell recovery confirmed
- Received immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 3 days prior to reinfusion
- Received live vaccine or live therapeutic STD treatment within 2 weeks before screening
- Active hepatitis B (with HBV DNA above 500 IU/ml), hepatitis C, HIV, or syphilis infection
- Active infection requiring intravenous antibiotics or hospitalization
- Significant cardiovascular disease including high NT proBNP, severe heart failure, recent unstable angina, myocardial infarction, or recent cardiac interventions
- Known allergy or severe reaction to PRG-1801 components or related drugs
- Other conditions deemed unsuitable for lymphocyte clearance, cell infusion, or study participation by investigators
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-1801 (BCMA-targeting CAR-T Cells) infusion to evaluate safety and efficacy for refractory lupus nephritis and IgG4-related disease.
Multiple visits including baseline and frequent early post-infusion visits (Day 2, 6, 10, 14, 21, 28) followed by scheduled assessments at 2, 3, 6, 9, 12, 18, and 24 months
Duration - Up to 24 months after treatment
Participants are monitored for safety, disease activity, and response to treatment for up to 24 months after PRG-1801 infusion.
Scheduled visits at 1, 2, 3, 6, 9, 12, 18, and 24 months post-infusion
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Lingli Dong, MD
Z
Ziwei Hu, MD
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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