Abstract Background Three CD19-directed CAR T-cell therapies - axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), and tisagenlecleucel (tisa-cel) - are FDA-approved for relapsed/refractory large B-cell lymphoma (R/R LBCL) following ≥2 prior lines of therapy or early relapse within 12 months of first-line treatment. Clinical studies have shown ORRs of 52-83% (CR 40-58%) in ≥3rd-line and 46-86% (CR 28-66%) in 2nd-line settings, with median PFS of 2.9-6.8 months (≥3rd-line) and 14.7 months (2nd-line, ZUMA-7 trial), respectively. In China, axi-cel and relma-cel (a CD19 CAR-T therapy developed based on liso-cel's technology but with a modified manufacturing process) have been approved for R/R LBCL. Previous studies suggested that combining CAR T-cell therapy with high-dose therapy/autologous stem cell transplantation (HDT/ASCT) may improve response rates and survival in R/R LBCL (Cao et al., 2021; Liu et al., 2024). However, these studies utilized investigational or compassionate-use CAR-T products. In this study, we report single-center outcomes from combining commercial CAR-T products (axi-cel and relma-cel) with HDT/ASCT for R/R LBCL. Methods We retrospectively analyzed patients with R/R LBCL or transformed LBCL who received combination therapy of commercial CAR T-cell therapy (axi-cel or relma-cel) and HDT/ASCT from January 2022 to December 2024 at the Institute of Hematology grade 2 in 1 patient, grade 4 in 2 patients). No treatment-related mortality or unexpected toxicities were observed. Conclusions The combination of axi-cel/relma-cel with HDT/ASCT demonstrates promising efficacy and acceptable safety in patients with R/R LBCL, representing a viable therapeutic option for transplantation-eligible candidates.
Liu et al. (Mon,) studied this question.
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