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Manufacturing results of tisagenlecleucel for acute lymphoblastic leukemia: a survey by the CAR-T cell therapy taskforce of the Japan Society of Transfusion Medicine and Cell Therapy
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- JO Tomoyasu
- Department of Clinical Laboratory Medicine and Center for Research and Application of Cellular Therapy, Kyoto University Hospital Department of Hematology and Oncology, Kyoto University Hospital
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- HENZAN Tomoko
- Center for Cellular and Molecular Medicine, Kyushu University Hospital
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- TOMIZAWA Daisuke
- Children's Cancer Center, National Center for Child Health and Development
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- YOSHIHARA Satoru
- Department of Cellular Therapy and Transfusion Medicine, Hyogo Medical University Hospital Department of Hematology, Hyogo Medical University Hospital
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- KAHATA Kaoru
- Department of Hematology, Hokkaido University Faculty of Medicine
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- YAMADA-FUJIWARA Minami
- Division of Blood Transfusion and Cell Therapy, Tohoku University Hospital
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- OKUYAMA Yoshiki
- Division of Transfusion and Cell Therapy, Tokyo Metropolitan Komagome Hospital
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- SHIBA Norio
- Department of Division of Blood Transfusion and Cell Therapy, Yokohama City University
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- FUJII Keiko
- Division of Transfusion, Okayama University Hospital
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- UMEZAWA Yoshihiro
- Department of Hematology, Tokyo Medical and Dental University
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- YAMAZAKI Rie
- Center for Transfusion Medicine and Cell Therapy, Keio University School of Medicine
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- TAKEDA Wataru
- Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital
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- HANAJIRI Ryo
- Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
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- FUKUSHIMA Kentaro
- Department of Hematology and Oncology, Osaka University Graduate School of Medicine
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- MIMURA Naoya
- Department of Transfusion Medicine and Cell Therapy, Chiba University Hospital
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- IKEMOTO Junko
- Department of Cellular Therapy and Transfusion Medicine, Hyogo Medical University Hospital
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- IWAKI Keita
- Division of Blood Transfusion and Cell Therapy, Tohoku University Hospital
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- YONETANI Noboru
- Department of Hematology, Kobe City Medical Center General Hospital
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- FUJIWARA Shin-ichiro
- Division of Cell Transplantation and Transfusion, Jichi Medical University Hospital
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- RI Masaki
- Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences
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- NAGAMURA-INOUE Tokiko
- Department of Cell Processing and Transfusion, The Institute of Medical Science, The University of Tokyo
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- TANOSAKI Ryuji
- Center for Transfusion Medicine and Cell Therapy, Keio University School of Medicine
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- ARAI Yasuyuki
- Department of Clinical Laboratory Medicine and Center for Research and Application of Cellular Therapy, Kyoto University Hospital Department of Hematology and Oncology, Kyoto University Hospital
Bibliographic Information
- Other Title
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- 急性リンパ性白血病に対するtisagenlecleucel製造結果
- 急性リンパ性白血病に対するtisagenlecleucel製造結果 : 日本輸血・細胞治療学会CAR-T療法タスクフォースによる研究
- キュウセイ リンパセイ ハッケツビョウ ニ タイスル tisagenlecleucel セイゾウ ケッカ : ニホン ユケツ ・ サイボウ チリョウ ガッカイ CAR-T リョウホウ タスクフォース ニ ヨル ケンキュウ
- —日本輸血・細胞治療学会CAR-T療法タスクフォースによる研究—
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Description
<p>The frequency of the manufacturing failure of chimeric antigen receptor (CAR)-T cell therapy in clinical practice is unknown. To clarify the current state of how likely CAR-T cell production is to succeed or fail for B-cell acute lymphoblastic leukemia (B-ALL), we analyzed cases in which the production of tisagenlecleucel was performed for patients with B-ALL at 15 facilities in Japan from October 2019 to March 2022. Total 81 patients (47 males and 34 females) were analyzed. The median age at apheresis was 13 years (1-25) with a median number of prior treatments of 4 (1-9). The numbers of patients with histories of allogeneic transplantation, inotuzumab ozogamicin, or blinatumomab treatments were 51 (63.0%), 26 (32.1%), and 37 (45.7%), respectively. The median blast percentage and CD3+ cell counts in peripheral blood were 0% (0-91.5), and 611/µl (35-4,210) at apheresis, and the median number of CD3+ cells shipped was 2.2×109 (0.5-8.3). While cases with a history of heavy prior treatment before apheresis were included, no manufacturing failures were observed. Continuing to monitor the status of manufacturing failures is necessary as the number of B-ALL cases treated with CAR-T cell therapy increases.</p>
Journal
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- Rinsho Ketsueki
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Rinsho Ketsueki 64 (5), 331-337, 2023
The Japanese Society of Hematology