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FT819 + fludarabine + cyclophosphamide + bendamustine

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

Overview

This is a **combination regimen** comprising FT819, fludarabine, cyclophosphamide, and bendamustine, studied primarily in patients with relapsed or refractory B-cell malignancies including B-cell lymphoma, chronic lymphocytic leukemia (CLL), and precursor B-cell acute lymphoblastic leukemia (B-ALL). - **FT819** is an investigational allogeneic, off-the-shelf, induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19 on malignant B-cells. It is designed to provide a readily available CAR T-cell product without patient apheresis. - **Fludarabine** and **cyclophosphamide** are standard lymphodepleting agents with antineoplastic and immunosuppressive activity, widely used to prepare patients for cell therapy by reducing immune-mediated rejection and enhancing CAR-T cell expansion. - **Bendamustine** is a unique alkylating agent with antitumor activity, also used as an alternative or adjunct in lymphodepletion regimens. It demonstrates cytotoxicity against leukemic and lymphoma cells and may be used alone or sequentially with the other agents in conditioning regimens. This quadruple combination has been studied in phase 1 settings to assess safety, maximum tolerated dose, and anti-tumor activity in B-cell malignancy patients undergoing CAR-T therapy, or for severe autoimmune disease (such as SLE or lupus nephritis).

Other names
fludarabinecyclophosphamidebendamustine hydrochloride
02

Targets

DNA polymerase familyCD19 (B lymphocyte antigen CD19)DNA

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