Drug intelligence / Profile preview

FKC288

Development stage
Phase 1
Lead developer
Nanjing University
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

FKC288 is an investigational chimeric antigen receptor T cell (CAR-T) therapy developed by Nanjing University. It is designed to target both B-cell maturation antigen (BCMA) and CD19, making it a dual-targeted CAR-T product. The mechanism of action involves BCMA agonism and CD19 inhibition, leading to immunologic cytotoxicity against pathogenic B cells implicated in autoimmune diseases and certain hematological conditions. The therapy is currently being evaluated in phase 1 clinical trials for relapsed or refractory systemic light chain (AL) amyloidosis as well as various autoimmune kidney diseases such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related disease[1][2][5][7]. Manufacturing involves leukapheresis to collect patient T cells which are then genetically modified ex vivo to express the CAR construct before reinfusion.

02

Targets

CD19 (B lymphocyte antigen CD19)BCMA (B-cell maturation antigen)

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