Actively Recruiting
Evaluation of the Safety and Efficacy of BCMA/CD19 Dual Targeted CAR-T Cell Therapy in Adults With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Trial
Led by Nanjing University School of Medicine · Updated on 2025-06-11
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effects of a new treatment called BCMA/CD19 dual targeted CAR-T cell therapy in adults with relapsed or refractory autoimmune kidney diseases such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases. This exploratory, open-label clinical trial uses a dose-escalation design to study different dose levels of the CAR-T cells. The study aims to better understand the treatment's safety and potential to control these kidney conditions. Participants will undergo a leukapheresis procedure to collect their T cells, which are then modified to create the FKC288 CAR-T cells. Before receiving the CAR-T cells, participants will have lymphodepletion treatment with fludarabine and cyclophosphamide for three days. After one day of rest, they will receive a single intravenous infusion of CAR-T cells at one of four dose levels ranging from 0.1 to 3.0 million CAR+ T cells per kilogram. The study plans to enroll 6 to 12 participants divided among these dose groups. During the study, participants will be followed for at least two years after receiving the CAR-T cell infusion. Researchers will monitor safety by checking for dose-limiting toxicities and adverse events within the first 28 days and 24 weeks respectively. They will also assess kidney responses, duration of response, progression-free survival, and overall survival over two years. Various clinical and laboratory evaluations will be performed throughout the study to track participants’ health and treatment effects.
CONDITIONS
Brief 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 aged 18 to 65 years
- Signed informed consent approved by the Ethics Committee
- Diagnosis of active, relapsing, or refractory lupus nephritis confirmed by kidney biopsy within 2 years with specific pathological types and clinical criteria
- Diagnosis of ANCA-associated vasculitis meeting 2012 criteria with renal involvement or refractory/relapsing disease defined by BVAS scores
- Diagnosis of PLA2R-related membranous nephropathy with high-risk or relapsing/refractory features and eGFR ≥ 45 ml/min/1.73 m²
- Diagnosis of IgG4-related disease meeting 2019 criteria with active, relapsing, or refractory disease
- Expected survival of at least 12 weeks
- ECOG performance status of 0 to 2
- Female participants of childbearing potential must agree to use effective contraception until 365 days after infusion
- Adequate organ function including specific blood counts before enrollment
You will not qualify if you...
- Previous gene therapy or live vaccine within 4 weeks before enrollment
- Receipt of other investigational drugs within 12 weeks before apheresis
- Active malignancies within 5 years except certain cured tumors
- Positive for Hepatitis B, C, HIV, CMV, or syphilis with abnormal tests
- Uncontrolled active infections except mild urinary or respiratory infections
- Severe heart diseases including recent myocardial infarction, heart failure NYHA class ≥ III, or severe arrhythmias
- Uncontrolled hypertension or diabetes
- Unresolved toxic reactions to prior treatments except mild cases
- Recent major surgery or planned surgery during treatment period except minor local anesthesia
- History of solid organ transplant
- Pregnant or breastfeeding women
- History of central nervous system diseases or consciousness disorders
- Other unstable systemic diseases judged unsuitable
- Known severe allergic reactions to FKC288 or components
- Bleeding or thrombosis disorders or current anticoagulant therapy
- Recent B cell-depleting therapies within 6 months
- Recent high-dose methylprednisolone or cyclophosphamide pulse therapy
- Inability to discontinue immunosuppressants before apheresis or high-dose steroids
- Eosinophilic granulomatosis with polyangiitis or active alveolar hemorrhage in AAV patients
- Other conditions deemed unsuitable by the researcher
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 - Variable period before lymphodepletion
Participants undergo leukapheresis to collect cells for manufacturing the CAR-T therapy. Bridging therapy may be given between cell collection and lymphodepletion.
1 to 2 visits depending on procedures
Duration - Approximately 1 week
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide for three consecutive days, followed by a single infusion of the BCMA/CD19 dual targeted CAR-T cells after one day of rest.
4 visits (3 days of lymphodepletion, 1 day rest, 1 infusion visit)
Duration - At least 2 years
Participants are monitored for safety, treatment response, and long-term outcomes after CAR-T cell infusion.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Jinling Hospital
Nanjing, Jiangsu, China, 210016
Actively Recruiting
Research Team
X
Xianghua Huang, MD
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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