大 B 细胞淋巴瘤 CD19 CAR-T 细胞治疗后的器官并发症：来自 EBMT 移植并发症与淋巴瘤工作组的回顾性研究

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.