End Points and Assessments
neurotoxicity, CRS, Cancer
ADVERSE EVENT, SYNDROME, CANCER
The primary end point was overall response rate (ORR) by the independent review committee (IRC) using Lugano criteria.Imaging assessments for efficacy (mandatory fluorodeoxyglucose positron emission tomography and either computed tomography or magnetic resonance imaging), along with MRD evaluation and physical examination, took place at weeks 6, 12, 18, 24, 36, and 48 and every 24 weeks thereafter.AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 24.1, and severity was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. CRS and immune effector cell–associated neurotoxicity syndrome (ICANS) were graded using criteria from the American Society for Transplantation and Cellular Therapy criteria.