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).
Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.
Participants must be aged ≥18 and ≤65 years.
Expected survival ≥ 12 weeks.
ECOG performance status ≤ 2.
Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.
Participants with uncontrolled active infections (except for < Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections).
Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias.
Single group
FKC289
DrugThe autologous dual target BCMA/CD19-CAR-T cell of this study is obtained by infecting T cells with anti-BCMA/CD19-CAR lentiviral vectors. Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
The proportion of subjects with dose-limiting toxicity
The number of participants with dose limiting toxicity in each dose group and the type of dose limiting toxicity that occurred.
The proportion of subjects with adverse events
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria.
Proportion of subjects achieving renal response
The proportion of participants who achieve partial remission (PR) or complete remission (CR) of renal.
Duration of response (DoR) of all subjects
The time from FKC289 infusion to the first assessment of CR/PR until the first assessment of disease progression/relapse or death due to the study disease
Progression-free survival (PFS) of all subjects
Time from the first FKC289 infusion to the first assessment of disease progression/relapse or death from any cause.
Overall survival (OS) of all subjects
Time from the first FKC289 infusion to death from any cause.
Click on the lead sponsor to view all of their trials.
