Drug intelligence / Profile preview

FT819 + cyclophosphamide

Development stage
Unknown
Lead developer
Fate Therapeutics
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies, Small Molecules
Administration
Intravenous
01

Overview

FT819 + cyclophosphamide is an investigational combination regimen consisting of FT819, an off-the-shelf, induced pluripotent stem cell (iPSC)-derived, CD19-targeted chimeric antigen receptor (CAR) T-cell therapy, and cyclophosphamide, a small-molecule alkylating chemotherapy used as a lymphodepleting conditioning agent. Developed by Fate Therapeutics, this fludarabine-free regimen is designed to deplete disease-causing CD19-positive B cells and allow a healthy immune system to rebuild. It is primarily being evaluated in a Phase 1 clinical trial (NCT06308978) for the treatment of moderate-to-severe B-cell-mediated autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis, systemic sclerosis, idiopathic inflammatory myositis, and ANCA-associated vasculitis.

Other names
FT-819 + cyclophosphamideFT-819 plus cyclophosphamideFT819 plus cyclophosphamideFT 819 plus cyclophosphamide

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