Organ complications after CD19 CAR T-cell therapy for large B cell lymphoma: a retrospective study from the EBMT transplant complications and lymphoma working party.

We investigated ≥ grade 3 (CTC-AE) organ toxicities for commercial CD19 chimeric antigen receptor T cell (CAR-T cell) products in 492 patients (Axi-Cel; n = 315; Tisa-Cel; n = 177) with Large B-cell Lymphoma in the European Society for Blood and Marrow Transplantation (EBMT) CAR-T registry. The incidence of ≥ grade 3 organ toxicities during the first 100 days after CAR-T was low and the most frequent were: renal (3.0%), cardiac (2.3%), gastro-intestinal (2.3%) and hepatic (1.8%). The majority occurred within three weeks after CAR-T cell therapy. Overall survival was 83.1% [79.8-86.5; 95% CI] at 3 months and 53.5% [49-58.4; 95% CI] at one year after CAR-T. The most frequent cause of death was tumour progression (85.1%). Non-relapse mortality was 3.1% [2.3-4.1; 95% CI] at 3 months and 5.2% [4.1-6.5; 95% CI] at one year after CAR-T. The most frequent causes of non-relapse mortality were cell-therapy-related toxicities including organ toxicities (6.4% of total deaths) and infections (4.4% of total deaths). Our data demonstrates good safety in the European real-world setting.
Competing Interests: OP has received honoraria or travel support from Gilead, Jazz, MSD, Novartis, Pfizer and Therakos. He has received research support from Incyte and Priothera. He is member of advisory boards to Equillium Bio, Jazz, Gilead, Novartis, MSD, Omeros, Priothera, Sanofi, Shionogi and SOBI. CC: BELLICUM PHARMACEUTICALS: Membership on an entity’s Board of Directors or advisory committees, BMS/CELGENE: Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; EBMT: Membership on an entity’s Board of Directors or advisory committees; FRESENIUS KABI: Research Funding; GILEAD: Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau, Honoraria; JANSSEN PHARMACEUTICALS: Membership on an entity’s Board of Directors or advisory committees; MILTENYI BIOTECH: Research Funding; NOVARTIS: Speakers Bureau, SANOFI SA: Honoraria, Research Funding, Speakers Bureau, TERUMO BCT: Speakers Bureau. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2023 Penack, Peczynski, Koenecke, Polge, Sanderson, Yakoub-Agha, Fegueux, Daskalakis, Collin, Dreger, Kröger, Schanz, Bloor, Ganser, Besley, Wulf, Novak, Moiseev, Schoemans, Basak, Chabannon, Sureda, Glass and Peric.)