Description
This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills. Nicolaus Krger MD, is the current EBMT President, Professor of Medicine and Medical Director of the Department of Stem Cell Transplantation at the University Medical Center, Hamburg – Eppendorf, Germany John G. Gribben, MD DSc FRCP FRCPath, FMedSci, is the Past President of EHA, Professor of Medical Oncology and Director of Stem Cell Transplantation at Saint Bartholomew’s Hospital, Queen Mary School of Medicine, University of London, UK Christian Chabannon, MD, PhD, is the current chair of the Cellular Therapy & Immunobiology Working Party (CTIWP) of the EBMT, is the Head and Qualified Person of the Cell Collection and Cell Processing Facility at Institut Paoli-Calmettes, the Coordinator of the “Centre d’Investigations Cliniques en Biothrapies de Marseille”, and a Professor of Cell Biology at Aix-Marseille University, France Ibrahim Yakoub-Agha, MD, PhD, is the current chair of the Chronic Malignancies Working Party of the EBMT and holds the position of coordinating professor for the Department of Hematology at Lille Faculty of Medicine, France Hermann Einsele, MD, FRCP, is Full Professor of Internal Medicine and has been Director of the Department of Internal Medicine II of the University Hospital Wrzburg, Germany 1. Introduction N Krger, J Gribben, C Chabannon, H Einsele, I Yakoub-Agha 2. The science behind CAR-T Cells J Gribben. 2. Structure of and signaling through the Chimeric Antigen Receptor 3. Genetic engineering of autologous or allogeneic immune effector cells 4. What defines a good tumor antigen? Minimizing or managing on target / off tumor and off target / off tumor effects 5. Mechanisms of resistance to CAR-T 6. The European landscape for preclinical and early clinical research Chapter 3. Manufacturing CAR-T Cells: the supply chain. C Chabannon. 7. Providing the starting material to the manufacturer of an approved and commercially available autologous CAR-T Cell treatment 8. Receiving, handling, storage, distribution, thawing and administration of the Gene Therapy Medicinal Product (GTMP) shipped from the manufacturing facility 9. Point-of-Care (POC) manufacturing of autologous CAR-T Cells 10. Off-the shelf allogeneic CAR-T Cells or other Immune Effector Cells (IECs) for the future 4. Clinical indications for CAR-T Cells. H Einsele. 11. Pediatric Acute Lymphoblastic Leukemia (ALL) 12. Adult Acute Lymphoblastic Leukemia (ALL) 13. Diffuse Large B Cell Lymphoma and Primary Mediastinal Lymphoma 14. Mantle Cell Lymphoma 15. Chronic Lymphocytic Leukemia 16 Indolent lymphomas 17. Multiple Myeloma 18. Developments in other hematological malignancies i. Other lymphoid malignancies ii. Myeloid Malignancies i. Developments in solid tumors 5. Clinical management of patients treated with CAR-T Cells. I Yakoub-Agha. 19. Bridging chemotherapy/ general chapter i. Adult ALL ii. Pediatric and young adult ALL iii. DLBCL, FL and indolent lymphomas iv. Multiple myeloma 20. Lymphodepleting Conditioning Regimens 21. Management of Cytokine Release Syndrome (CRS) 22. Management of Immune effector Cells Associated Neurotoxicity Syndrome (ICANS) 23. Management of hypogammaglobulinemia and B-cell aplasia 24. Management of myelotoxicity(aplasia) and infectious complications 25. Management of other toxicities 26. ICU i. Post CAR-T cell therapy (consolidation and relapse) i. ALL ii. Lymphomas iii. MM 27. Immune monitoring 28. Long-term follow-up and late effects 6. Access to CAR-T cells. N Krger 29. The regulatory framework for CAR-T cells in Europe: current status and foreseeable changes 30. Center qualification by competent authorities and manufacturers 31. How can accreditation bodies such as JACIE or FACT support centers in getting qualified? 32 Educational needs for physicians 33. Educational needs for nurses 34 Educational needs for pharmacists 25. Educational needs for Cell Collection and Cell Processing Facility personnel 36. GoCART project 37. Patient referral 38 Treatment coverage and reimbursement 39. Assessing the medical value of CAR-T Cells 40 What do patients want? The importance of patient reported outcome
