Open AccessThe FDA’s Regulatory Framework for Chimeric Antigen Receptor‐T Cell Therapies
Author(s) -
Marks Peter
Publication year - 2019
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12666
Subject(s) - chimeric antigen receptor , antigen , viral vector , genetic enhancement , transfection , immunology , medicine , cancer research , t cell , biology , immune system , virology , cell culture , gene , genetics , recombinant dna
Chimeric antigen receptor-T (CAR-T) cells are the product of several decades of work in different scientific disciplines that has culminated in the development and approval of therapies that are effective against certain relapsed or refractory hematologic malignancies. In addition, CAR-T cells are under investigation for the treatment of other hematologic malignancies and solid tumors, as well as autoimmune and infectious diseases.