Saad Usmani, MD, MBBS, MBA, Levine Cancer Institute, Charlotte, NC, shares details of the upcoming KarMMa-4 Phase I study (NCT04196491) of idecabtagene vicleucel (ide-cel, bb2121), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy, in high-risk newly diagnosed multiple myeloma. High-risk patients that are enrolled in to this multicenter, open-label trial will initially be treated with induction therapy followed by ide-cel infusion at a starting target dose of 450 x 10^6 CAR+ T cells, with dose escalation/de-escalation. Following identification of the optimal target dose, further patients will be enrolled for the dose-expansion phase. It is hoped that trials such as this will support the initiation of future studies into the use of CAR-T therapies in the newly diagnosed setting for high-risk myeloma. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Saad Usmani, MD, MBBS, MBA, has received research funding from Amgen, Array Biopharma, BMS, Celgene, GSK, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX and Takeda; has received consulting fees from Abbvie, Amgen, BMS, Celgene, GSK, Genentech/Roche, Janssen, Karyopharm, Merck, Oncopeptides, Sanofi, Seattle Genetics, SkylineDx and Takeda; and has received speaking fees from Celgene, Janssen, Sanofi and Takeda.