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ORIGINAL RESEARCH article

Front. Pediatr.
Sec. Pediatric Hematology and Hematological Malignancies
Volume 12 - 2024 | doi: 10.3389/fped.2024.1485402

Title：Impact of corticosteroids on the efficacy of CD19/22 CAR T-cell therapy in pediatric and youngsters with B-ALL: a single center study

Provisionally accepted
Jing Yang Jing Yang 1Jing Zhang Jing Zhang 1*Xinyu Wan Xinyu Wan 1CAI JIAOYANG CAI JIAOYANG 1Tianyi Wang Tianyi Wang 1*Xiaomin Yang Xiaomin Yang 1Wenjie Li Wenjie Li 1*Lixia Ding Lixia Ding 1*Lili Song Lili Song 1*Yan Miao Yan Miao 1*Xiang Wang Xiang Wang 1*Yani Ma Yani Ma 1*Chengjuan Luo Chengjuan Luo 1*Jingyan Tang Jingyan Tang 1*Longjun Gu Longjun Gu 1*Jing Chen Jing Chen 1Jun Lu Jun Lu 2*Tang Yanjing Tang Yanjing 1*Benshang Li Benshang Li 1*
  • 1 Shanghai Children's Medical Center, Shanghai, China
  • 2 Children's Hospital of Soochow University, Suzhou, Jiangsu Province, China

The final, formatted version of the article will be published soon.

    Corticosteroids are used for toxicity management-raising concerns about whether they may affect Chimeric antigen receptor T-cell (CAR-T) anti-leukemic effects. Here we retrospectively analyzed relapsed or refractory B-ALL patients (<20 years old) treated with our center preparative CD19/22 CAR T cells (Trial Registration No. ChiCTR2000032211). Among 194 patients evaluated, 88% had any grade CRS reaction. We defined two sub-groups based on disease burden. In which 75 cases in the low-disease burden(LDB) group (MRD<5%, no extramedullary disease), there was no significant difference between the use of steroids and the EFS (p = 0.21) and OS (p = 0.26), and the same with 119 cases in the high-disease burden(HDB) group. When eliminate the effect of consolidative transplantation on prognosis, the EFS of patients who did not use steroids was better (p = 0.037) in the LDB group, but the difference is not significant in the HDB group. The median cumulative dexamethasone-equivalent dose was 0.56 mg/kg, and the EFS and OS were similar among different cumulative dose groups. Also, there was no difference in the recovery of B cells and the expansion of the CAR T-cell copies. In conclusion, under the guidance of current CRS prevention and control measures, rational use of corticosteroids does not affect the clinical efficacy and overall survival of CAR-T therapy in B-ALL patients, and also does not affect the persistence of CAR T cells in vivo, but the dosage threshold needs further clinical or experimental verification.

    Keywords: Leukemia, Chimeric Antigen Receptor, cytokine release syndrome, corticosteroids, Children

    Received: 23 Aug 2024; Accepted: 25 Oct 2024.

    Copyright: © 2024 Yang, Zhang, Wan, JIAOYANG, Wang, Yang, Li, Ding, Song, Miao, Wang, Ma, Luo, Tang, Gu, Chen, Lu, Yanjing and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Jing Zhang, Shanghai Children's Medical Center, Shanghai, China
    Tianyi Wang, Shanghai Children's Medical Center, Shanghai, China
    Wenjie Li, Shanghai Children's Medical Center, Shanghai, China
    Lixia Ding, Shanghai Children's Medical Center, Shanghai, China
    Lili Song, Shanghai Children's Medical Center, Shanghai, China
    Yan Miao, Shanghai Children's Medical Center, Shanghai, China
    Xiang Wang, Shanghai Children's Medical Center, Shanghai, China
    Yani Ma, Shanghai Children's Medical Center, Shanghai, China
    Chengjuan Luo, Shanghai Children's Medical Center, Shanghai, China
    Jingyan Tang, Shanghai Children's Medical Center, Shanghai, China
    Longjun Gu, Shanghai Children's Medical Center, Shanghai, China
    Jun Lu, Children's Hospital of Soochow University, Suzhou, 215003, Jiangsu Province, China
    Tang Yanjing, Shanghai Children's Medical Center, Shanghai, China
    Benshang Li, Shanghai Children's Medical Center, Shanghai, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.