This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D). And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects with hematologically best complete response (CR) within 6 months.
Voluntarily signed the informed consent form (ICF);
Aged between 18-75 years old (inclusive);
Confirmed clinical diagnosis of primary light chain (AL) amyloidosis;
Relapsed or refractory disease;
Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
Clinically significant central nervous system (CNS) disease or pathological abnormality;
History of solid organ transplantation (e.g., heart, lung, kidney, liver);
Presence of complete intestinal obstruction;
Sequential
FKC289 infusion
DrugAnti-BCMA/CD19 chimeric antigen receptor autologous T cells
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Hematologic complete response rate (CRR)
Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Hematologic objective response rate (ORR)
Proportion of subjects achieving hematologic objective response according to the NCCN 2023
Pharmacokinetics (PK)
Levels of CAR-T cells in peripheral blood
Pharmacodynamics (PD)
Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood
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