Perspectives on outpatient administration of CAR-T cell therapy in aggressive B-cell lymphoma and acute lymphoblastic leukemia.

Chimeric antigen receptor (CAR) T-cell therapies that specifically target the CD19 antigen have emerged as a highly effective treatment option in patients with refractory B-cell hematological malignancies. Safety and efficacy outcomes from the pivotal prospective clinical trials of axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel and the retrospective, postmarketing, real-world analyses have confirmed high response rates and durable remissions in patients who had failed multiple lines of therapy and had no meaningful treatment options. Although initially administered in the inpatient setting, there has been a growing interest in delivering CAR-T cell therapy in the outpatient setting; however, this has not been adopted as standard clinical practice for multiple reasons, including logistic and reimbursement issues. CAR-T cell therapy requires a multidisciplinary approach and coordination, particularly if given in an outpatient setting. The ability to monitor patients closely is necessary and proper protocols must be established to respond to clinical changes to ensure efficient, effective and rapid evaluation either in the clinic or emergency department for management decisions regarding fever, sepsis, cytokine release syndrome and neurological events, specifically immune effector cell-associated neurotoxicity syndrome. This review presents the authors' institutional experience with the preparation and delivery of outpatient CD19-directed CAR-T cell therapy.

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Déclaration de conflit d'intérêts

Competing interests: GDM serves as a consultant on the study steering committee for Kymriah (tisagenlecleucel) and on the Speaker's Bureau for Kymriah (tisagenlecleucel). MRV reports salary and stock consultancy for Fate Therapeutics and reports salary from and serves on an advisory board for Novartis. AG has received consulting fees and his institution has received research funding from Acerta, Celgene, Constellation, Infinity, Infinity Verastem, Janssen, Karyopharm, Kite Pharma, Pharmacyclics, Genentech-Hoffman La Roche, AstraZeneca, Genentech and Hoffman La Roche. He is a consultant for Acerta, Celgene, Janssen, Kite Pharma, Pharmacyclics, Gilead, Medscape, MJH Associates, Physicians Education Resource and Xcenda. He has served on advisory boards for Janssen, Kite Pharma, Elsevier’s PracticeUpdate Oncology, and Gilead; has served as a moderator for OncLive Peer Exchange; and has served as an Advisor on Video for AstraZeneca. He is a member of steering committees for AstraZeneca and MorphoSys and Incyte. RTM is a member and chair of the Scientific Steering Committee for Tisagenlecleucel for DLBCL and receives honoraria and research funding from Novartis. He is a consultant for and receives honoraria from CRISPR Therapeutics, Incyte, and Juno Therapeutics; receives honoraria from Kite Therapeutics; and has patents and receives royalties from Athersys. RTM is employed by Oregon Health & Science University (OHSU) and has provided consultant services to and received payment from Novartis. This potential conflict of interest has been reviewed and managed by OHSU.