Safety and efficacy of a novel anti-CD19 chimeric antigen receptor T cell product targeting a membrane-proximal domain of CD19 with fast on- and off-rates against non-Hodgkin lymphoma: a first-in-human study.

"Declarations Competing interestsMR holds patents related to CD19 CAR T cells (non-AT101) which are licensed to Novartis, Tmunity (Kite-Gilead), and viTToria Biotherapeutics. MR has served as a consultant for NanoString, BMS, GSK, GLG, Sana, Bayer, Guidepoint, Scailyte, and AbClon. MR receives research funding from AbClon, Beckman Coulter, CurioX, Oxoford Nano Imaging, and viTToria Biotherapeutics. MR is the scientific founder of viTToria biotherapeutics. RPP and GG received honoraria for consultation with viTToria Biotherapeutics. DHY has served as a consultant for Roche, Janssen, Amgen, BMS, Novartis, AbClon, GI cell, GC cell, and Pharos Bio. DHY receives honoraria from Roche, Janssen, Amgen, BMS, Kirin, Boryung, and Takeda. DHY receives research funding from Samyang, Kirin, Roche, Janssen and Boryung. Competing interests MR holds patents related to CD19 CAR T cells (non-AT101) which are licensed to Novartis, Tmunity (Kite-Gilead), and viTToria Biotherapeutics. MR has served as a consultant for NanoString, BMS, GSK, GLG, Sana, Bayer, Guidepoint, Scailyte, and AbClon. MR receives research funding from AbClon, Beckman Coulter, CurioX, Oxoford Nano Imaging, and viTToria Biotherapeutics. MR is the scientific founder of viTToria biotherapeutics. RPP and GG received honoraria for consultation with viTToria Biotherapeutics. DHY has served as a consultant for Roche, Janssen, Amgen, BMS, Novartis, AbClon, GI cell, GC cell, and Pharos Bio. DHY receives honoraria from Roche, Janssen, Amgen, BMS, Kirin, Boryung, and Takeda. DHY receives research funding from Samyang, Kirin, Roche, Janssen and Boryung."

"Funding AbClon Inc. funded the preclinical and clinical studies. The sponsor worked with the principal investigators in the conceptualization, design, preclinical and manufacturing data collection and analysis, decision to publish, and preparation of the manuscript. The sponsor had no role in the patient treatment decisions, clinical data collection, or analysis. This work was supported in part by grants from the National Institutes of Health (NIH) grant AI130197 (DL) and CA267368 (DL)."

"Trial registration NCT05338931; Date: 2022–04-01."