Actively Recruiting
The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
Led by Nanjing University School of Medicine · Updated on 2025-06-11
24
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).
CONDITIONS
Official Title
The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign informed consent approved by the Ethics Committee before starting the study.
- Aged 18 to 65 years.
- Have active, relapsing, or refractory lupus nephritis diagnosed by kidney biopsy within 2 years with specified pathology and clinical criteria.
- OR diagnosed with ANCA-associated vasculitis with renal involvement, including newly diagnosed, relapsing, or refractory cases.
- OR diagnosed with PLA2R-related membranous nephropathy meeting high-risk or relapsing/refractory criteria.
- OR diagnosed with IgG4-related disease meeting 2019 ACR/EULAR criteria with active or relapsing/refractory disease.
- Expected survival of at least 12 weeks.
- ECOG performance status of 2 or less.
- Female participants of childbearing potential must agree to effective contraception from consent until 365 days after infusion.
- Adequate organ function including specified neutrophil and platelet counts before enrollment.
You will not qualify if you...
- Prior gene therapy or live vaccine within 4 weeks before enrollment.
- Use of other investigational drugs within 12 weeks before apheresis.
- Active malignancies within 5 years except cured tumors like basal or squamous cell carcinoma.
- Positive for hepatitis B, C, HIV, CMV DNA, or syphilis with abnormal tests.
- Uncontrolled active infections (except minor urinary or upper respiratory infections).
- Severe heart disease including recent myocardial infarction, congestive heart failure class III or higher, and severe arrhythmias.
- Uncontrolled hypertension or diabetes.
- Unresolved toxicities from previous treatments worse than grade 1 (except alopecia or minor lab abnormalities).
- Major surgery within 2 weeks before enrollment or planned surgery during infusion waiting or 12 weeks after treatment (except minor local anesthesia surgeries).
- Solid organ transplant recipients.
- Pregnant or breastfeeding women.
- History of central nervous system diseases or consciousness disorders.
- Other unstable systemic diseases requiring medication.
- Known severe allergic reactions or intolerance to FKC288 or components.
- Bleeding or thrombosis disorders or on thrombolytic/anticoagulant therapy.
- Recent B cell-depleting or non-depleting therapy within 6 months.
- Recent high-dose methylprednisolone or cyclophosphamide pulse therapy within 1 month.
- Unable to stop other immunosuppressants or on prednisone above 5 mg/day one week before apheresis.
- AAV patients with eosinophilic granulomatosis or active alveolar hemorrhage.
- Other conditions deemed unsuitable by the researcher.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jinling Hospital
Nanjing, Jiangsu, China, 210016
Actively Recruiting
Research Team
X
Xianghua Huang, 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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