Developing and Monitoring a Standard-of-Care Chimeric Antigen Receptor (CAR) T Cell Clinical Quality and Regulatory Program.

Autor: Dulan SO; Department of Quality, Risk, and Regulatory Management, City of Hope National Medical Center, Duarte, California., Viers KL; Department of Quality, Risk, and Regulatory Management, City of Hope National Medical Center, Duarte, California., Wagner JR; Department of Hematology T Cell Therapeutics Research Laboratory, City of Hope Medical Center, Duarte, California., Clark MC; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California., Chang B; Department of Hematology T Cell Therapeutics Research Laboratory, City of Hope Medical Center, Duarte, California., Gorospe GL; Department of Nursing Support Hem/HCT Nurse Coordinator, City of Hope Medical Center, Duarte, California., Londrc A; Department of Hematology, Division of Transplant and Cellular Therapy Reporting, City of Hope Medical Center, Duarte, California., Brown AS; Department of Hematology, Division of Transplant and Cellular Therapy Reporting, City of Hope Medical Center, Duarte, California., Rosenthal J; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California., Smith EP; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California., Forman SJ; Department of Hematology T Cell Therapeutics Research Laboratory, City of Hope Medical Center, Duarte, California; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California., Snyder DS; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California. Electronic address: DSnyder@coh.org., Budde LE; Department of Hematology T Cell Therapeutics Research Laboratory, City of Hope Medical Center, Duarte, California; Department of Hematology, The Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, California. Electronic address: ebudde@coh.org.

Publikováno v: Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation [Biol Blood Marrow Transplant] 2020 Aug; Vol. 26 (8), pp. 1386-1393. Date of Electronic Publication: 2020 May 19.