Evidence map›Paper›PMID 35013456›Full record

Trial reportScientific reports2022

The differential effects of tumor burdens on predicting the net benefits of ssCART-19 cell treatment on r/r B-ALL patients.

Minghao Li, Sheng-Li Xue, Xiaowen Tang, Jiayu Xu, Suning Chen, Yue Han, Huiying Qiu, Miao Miao, Nan Xu, Jingwen Tan and 9 more

Registry-linked trialOpen access · goldAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03919240 (CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia), which is not on this map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
3.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03919240 phase1 / phase2active not recruitingnot on this map

CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

TypeinterventionalSponsorThe First Affiliated Hospital of Soochow UniversityRan2015 to 2027Enrolled196ConditionsAcute Lymphoblastic Leukemia With Failed RemissionArmsCAR T-cell therapy
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 6 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Dose fractionation of CAR-T cells. A systematic review of clinical outcomes.Journal of experimental & clinical cancer research : CR · 2023
    Pooled it
  7. Article
  8. Article
  9. Th17-driven CD8Cell death & disease · 2026
    Article
  10. A 3D engineered multiple myeloma niche for evaluating CAR T cell therapy.Frontiers in bioengineering and biotechnology · 2026
    Article
  11. Review
  12. Review
  13. Review
  14. Prospects of Synergy: Local Interventions and CAR T Cell Therapy in Solid Tumors.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  15. Chimeric Antigen Receptor T Cell with an Inducible Caspase-9 Suicide Gene Eradicates Uveal Melanoma Liver Metastases via B7-H3 Targeting.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  16. CAR-T Cell Therapy: the Efficacy and Toxicity Balance.Current hematologic malignancy reports · 2023
    Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 4 institutions in 1 country.

Minghao Li *Institute of Biomedical Engineering and Technology, Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development, School of Chemistry and Molecular Engineering, East China Normal University, NO, 3663 North Zhongshan Road, Shanghai, 200065, China.
Sheng-Li Xue *National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Xiaowen Tang *National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Jiayu XuInstitute of Intelligent System and Bioinformatics, College of Intelligent Systems Science and Engineering, Harbin Engineering University, Harbin, 150001, Heilongjiang, China.
Suning ChenNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Yue HanNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Huiying QiuNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Miao MiaoNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Nan XuInstitute of Biomedical Engineering and Technology, Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development, School of Chemistry and Molecular Engineering, East China Normal University, NO, 3663 North Zhongshan Road, Shanghai, 200065, China.
Jingwen TanInstitute of Biomedical Engineering and Technology, Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development, School of Chemistry and Molecular Engineering, East China Normal University, NO, 3663 North Zhongshan Road, Shanghai, 200065, China.
Liqing KangShanghai Unicar-Therapy Bio-Medicine Technology Co., Ltd, No 1525 Minqiang Road, Shanghai, 201612, China.
Zhou YuShanghai Unicar-Therapy Bio-Medicine Technology Co., Ltd, No 1525 Minqiang Road, Shanghai, 201612, China.
Xiaoyan LouShanghai Unicar-Therapy Bio-Medicine Technology Co., Ltd, No 1525 Minqiang Road, Shanghai, 201612, China.
Yang XuNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Jia ChenNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Zhiqiang YanInstitute of Biomedical Engineering and Technology, Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development, School of Chemistry and Molecular Engineering, East China Normal University, NO, 3663 North Zhongshan Road, Shanghai, 200065, China.
Weixing FengInstitute of Intelligent System and Bioinformatics, College of Intelligent Systems Science and Engineering, Harbin Engineering University, Harbin, 150001, Heilongjiang, China.
Depei WuNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China. wudepei@suda.edu.cn.
Lei YuInstitute of Biomedical Engineering and Technology, Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development, School of Chemistry and Molecular Engineering, East China Normal University, NO, 3663 North Zhongshan Road, Shanghai, 200065, China. ylyh188@163.com.
First Affiliated Hospital of Soochow University · CNEast China Normal University · CNSoochow University · CNHarbin Engineering University · CN

Funding

Jiangsu Province "333"project and Gusu Key Medical Talent Program GSWS2019007National Natural Science Foundation of China 81872812National Natural Science Foundation of China 81970138National Natural Science Foundation of China 82073800Translational Research Grant of NCRCH 2020ZKMB05
6 · The paper itself

Abstract

The tumor burden (TB) is significantly related to the severity of cytokine release syndrome (CRS) caused by CAR-T cells, but its correlation with therapeutic efficacy has not been systematically studied. This study focused on the effects of the TB level on both the safety and efficacy of ssCART-19 as a treatment for r/r B-ALL. Taking the 5% tumor burden as the boundary, the study participants were divided into 2 groups, high and low tumor burden groups. Under this grouping strategy, the impacts of differential r/r B-ALL TBs on the clinical therapeutic efficacy (CR rate and long-term survival) and safety profiles after ssCART-19 cell treatment were analysed. 78 patients were reported in this study. The differential B-ALL TBs significantly affected the complete remission (CR) rates of patients treated with ssCART-19, with rates of 93.94% and 75.56% in the low and high TB groups, respectively (P = 0.0358). The effects of TBs on long-term therapeutic efficacy were further studied based on event-free survival (EFS) and overall survival (OS) profiles; both the OS and EFS of the low TB group were better than those of the high TB group, but the differences were not statistically significant. Importantly, the time points of TB measurement did not significantly affect the OS and EFS profiles regardless of whether the TBs were measured before or after fludarabine-cyclophosphamide (FC) preconditional chemotherapy. On the other hand, the severity of CRS was significantly correlated with the TB level (P = 0.0080), and the incidence of sCRS was significantly related to the TB level (the sCRS incidence increased as the TB level increased, P = 0.0224). Unexpectedly, the ssCART-19 cell expansion peaks were not significantly different (P = 0.2951) between the study groups. Patients with a low r/r B-ALL TB yield more net benefits from CAR-T treatment than those with a high TB in terms of safety and CR rate. These findings are critical and valuable for determining the optimal CAR-T cell treatment window for r/r B-ALL patients and will further the development of comprehensive and reasonable CAR-T cell treatment plans for r/r B-ALL patients with differential TBs.Trial registration: ClinicalTrials.gov identifier, NCT03919240.

Indexed as

Immunotherapy, AdoptiveAdolescentAdultAgedChildChinaCytokine Release SyndromeFemaleHumansMaleMiddle AgedPrecursor B-Cell Lymphoblastic Leukemia-LymphomaProgression-Free SurvivalReceptors, Chimeric AntigenRemission InductionRisk FactorsReceptors, Chimeric Antigen

Identifiers

PMID35013456
PMCPMC8748521
OpenAlexW4206001535

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.