학술논문

Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Transplantation and Cellular Therapy
Document Type
article
Source
Transplantation and Cellular Therapy. 25(3)
Subject
Biomedical and Clinical Sciences
Oncology and Carcinogenesis
Immunology
Transplantation
Childhood Leukemia
Pediatric Cancer
Pediatric
Biotechnology
Orphan Drug
Genetics
Pediatric Research Initiative
Cancer
Rare Diseases
Gene Therapy
Immunization
Hematology
Development of treatments and therapeutic interventions
5.2 Cellular and gene therapies
Good Health and Well Being
Antigens
CD19
Child
Critical Pathways
Drug Approval
Expert Testimony
Humans
Immunotherapy
Adoptive
Practice Patterns
Physicians'
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Receptors
Antigen
T-Cell
Societies
Medical
United States
Young Adult
Chimeric antigen receptor
Leukemia
T cell
Clinical Sciences
Cardiovascular medicine and haematology
Language
Abstract
On August 30, 2017 the US Food and Drug Administration approved tisagenlecleucel (Kymriah; Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present, ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring, and disease assessments. To address these issues experts representing the American Society for Blood and Marrow Transplant, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved.