Low platelet counts and low CD4/CD8 ratios at apheresis increase the risk of CAR T-cell manufacturing failure in myeloma

作者：Tomoyasu Jo, Kyoko Yoshihara, Masaki Ri, Nobuhiro Tsukada, Naoya Mimura, Keiko Fujii, Kentaro Fukushima, Shin‐ichiro Fujiwara, Yuji Shimura, Kyoko Haraguchi, Koji Kato, Atsushi� Satake, Akiyo Yoshida, Rikio Suzuki, Junko Ikemoto, Keita Iwaki, Wataru Takeda, Noboru Yonetani, Ryuji Tanosaki, Minami Yamada‐Fujiwara, Kaoru Kahata, Tokiko Nagamura‐Inoue, Satoshi Yoshihara, Yasuyuki Arai · 发表于：Blood Neoplasia · 年份：2024 · DOI：10.1016/j.bneo.2024.100051 · 被引用次数：4 · 研究领域：CAR-T cell therapy research、Multiple Myeloma Research and Treatments、Chronic Lymphocytic Leukemia Research

• Low platelet counts and low CD4/CD8 T-cell ratios at apheresis increase the risk of CAR T-cell manufacturing failure in multiple myeloma. • Alkylating agents within 6 months before apheresis were associated with decreased platelet counts and CD4/CD8 ratios at apheresis. Chimeric antigen receptor (CAR) T-cell (CAR-T) therapy has significantly improved management of relapsed or refractory multiple myeloma. However, manufacturing failure due to poor cell growth necessitates revision of treatment strategies that negatively impact patients. To identify risk factors for CAR-T manufacturing failure in patients with myeloma, a nationwide cohort study was performed, analyzing patients who underwent apheresis for idecabtagene vicleucel in Japan. Of 154 patients analyzed, 13 cases (8.4%) experienced manufacturing failure. We compared clinical factors between patients with manufacturing failure (failed group) and those who met specifications (successful group). Patients in the failed group had a higher prevalence of deletion 17p at diagnosis (38.5% vs 14.9%), were more likely to have been treated with alkylating agents within 6 months before apheresis (53.8% vs 23.4%), and had undergone more chemotherapy lines before apheresis (median, 6 vs 5). Additionally, patients with manufacturing failure exhibited significantly lower hemoglobin levels (8.6 vs 10.0 g/dL), platelet counts (5.9 × 10 4 /μL vs 13.8 × 10 4 /μL), and CD4/CD8 ratios (0.169 vs 0.474) than patient with successful manufactu...