Evidence map›Paper›PMID 39244642›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2025

Autologous CD7 CAR-T cells generated without T cell pre-selection in pediatric patients with relapsed/refractory T-ALL: A phase I trial.

Liping Zhao, Chuo Li, Shiyu Zuo, Yajing Han, Biping Deng, Zhuojun Ling, Yanlei Zhang, Shuixiu Peng, Jinlong Xu, Jiajia Duan and 14 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04840875 (Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT04840875 phase1completednot on this map

Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma

TypeinterventionalSponsorBeijing Boren HospitalRan2021 to 2023Enrolled16ConditionsT Cell Lymphoma, T-cell LeukemiaArmschimeric antigen receptor T cell treatment
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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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

24 authors.

Liping ZhaoState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China; Department of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China.
Chuo LiState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Shiyu ZuoState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Yajing HanState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Biping DengCytology Laboratory, Beijing GoBroad Boren Hospital, Beijing 100070, China.
Zhuojun LingDepartment of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China.
Yanlei ZhangShanghai YaKe Biotechnology Ltd., Shanghai 200438, China.
Shuixiu PengShanghai YaKe Biotechnology Ltd., Shanghai 200438, China.
Jinlong XuDepartment of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China.
Jiajia DuanDepartment of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China.
Zelin WangDepartment of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China.
Xinjian YuMedical Laboratory, Beijing GoBroad Boren Hospital, Beijing 100070, China.
Qinlong ZhengMedical Laboratory, Beijing GoBroad Boren Hospital, Beijing 100070, China.
Xiuwen XuMedical Laboratory, Beijing GoBroad Boren Hospital, Beijing 100070, China.
Ying YuanDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Austin, TX 77030, USA.
Zhenglong TianGobroad Research Center, GoBroad Medical Group, Beijing 100070, China.
Kaiting TangState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Yibing ZhangState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Qing NiuState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China.
Jiecheng ZhangDepartment of Hospital Management, GoBroad Medical Group, Beijing 100070, China.
Alex H ChangShanghai YaKe Biotechnology Ltd., Shanghai 200438, China; Engineering Research Center of Gene Technology, Ministry of Education, Institute of Genetics, School of Life Science, Fudan University, Shanghai 200438, China.
Yuechen LuoState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China. Electronic address: luoyuechen@ihcams.ac.cn.
Xiaoming FengState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Tianjin Institutes of Health Science, Tianjin 301600, China; Central laboratory, Fujian Medical Union Hospital, Fuzhou 350001, China; CAMS Key Laboratory for Prevention and Control of Hematological Disease Treatment Related Infection, Tianjin 300020, China. Electronic address: fengxiaoming@ihcams.ac.cn.
Jing PanDepartment of Hematology, Key Laboratory of Experimental Hematology, Boren Clinical Translational Center, Beijing Gobroad Boren Hospital, Beijing 100070, China. Electronic address: panj@gobroadhealthcare.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chimeric antigen receptor (CAR)-T cell therapy showed preliminary activity in patients with refractory or relapsed T cell acute lymphoblastic leukemia (r/r T-ALL). However, many obstacles remain, including manufacturing difficulties and risk of infections. This phase I study (NCT04840875) evaluated autologous CD7 CAR-T cells manufactured without pre-selection of healthy T cells in r/r T-ALL. Thirty patients (29 children and one adult) with a median of two lines of prior therapy but without detectable peripheral leukemia were enrolled. Excluding three cases of manufacturing failures, a total of 27 (90%) patients received infusions after products were confirmed free of leukemia contamination, including 16 (59%) meeting planned target doses. Common adverse events within 30 days included grade 3-4 cytopenias (100%), grade 1-2 (70%) and 3-4 (7%, including one dose-limiting toxicity) cytokine release syndrome, grade 1 neurotoxicity (7%), grade 2 infection (4%), and grade 2 graft-versus-host disease (4%). Two patients developed grade 2 infections after day 30. At day 30, 96% responded and 85% achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi). Seventy-four percent underwent transplantation. Twelve-month progression-free survival with and without censoring transplantation was 22% (95% confidence interval 4%-100%) and 57% (41%-81%), respectively. These results support that autologous CD7 CAR-T therapy without T cell pre-selection is feasible in patients with r/r T-ALL.

Indexed as

Antigens, CD7Immunotherapy, AdoptivePrecursor Cell Lymphoblastic Leukemia-LymphomaReceptors, Chimeric AntigenT-LymphocytesAdolescentAdultChildChild, PreschoolFemaleHumansMaleTransplantation, AutologousTreatment OutcomeYoung AdultAntigens, CD7Receptors, Chimeric AntigenCAR-TCD7safetystem cell transplantationT cell acute lymphoblastic leukemiaT cell pre-selection

Identifiers

PMID39244642
PMCPMC12172174

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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.