Evidence map›Paper›PMID 41123227›Full record

Trial reportCancer medicine2025

BTK Inhibitor Synergizes With CD19-Targeted Chimeric Antigen Receptor-T Cells in Patients With Relapsed or Refractory B-Cell Lymphoma: An Open-Label Pragmatic Clinical Trial.

Wenjing Luo, Yinqiang Zhang, Chenggong Li, Jia Xu, Zhuolin Wu, Xindi Wang, Yun Kang, Danying Liao, Haiming Kou, Wei Xie and 4 more

Registry-linked trialAbstract readPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05020392 (Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT05020392 phase3unknown statusnot on this map

Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2021 to 2024Enrolled24ConditionsDiffuse Large B Cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma, Chronic Lymphocytic LeukemiaArmsBTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells, Fludarabine-based chemotherapy + CAR-T-CD19 Cells
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. 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

14 authors.

Wenjing LuoInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yinqiang ZhangInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Chenggong LiInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jia XuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Zhuolin WuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xindi WangInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yun KangInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Danying LiaoInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Haiming KouInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Wei XieInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Wei XiongWuhan Sian Medical Technology Co., Ltd., Wuhan, China.
Jun DengInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Heng MeiInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.ORCID https://orcid.org/0000-0001-7941-2443
Yu HuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Funding

Huazhong University of Science and TechnologyNational Key Research and Development Program of China 2022YFC2502704National Natural Science Foundation of China 82330005National Natural Science Foundation of China 82350103
6 · The paper itself

Abstract

backgroundCD19-targeted chimeric antigen receptor-T cell (CART19) therapy is clinically effective in patients with relapsed or refractory B-cell lymphoma (BCL), but treatment failure and recurrence need to be overcome. Preclinical studies demonstrated that Bruton tyrosine kinase inhibitor (BTKi) improved the efficacy of CART19 therapy.

methodsWe designed this open-label, non-randomized pragmatic clinical trial. The primary end point was safety, and the secondary end point was clinical response.

resultsThirty-seven patients included were assigned to CART19 monotherapy (n = 24) or CART19 combined with BTKi (n = 13) group on their own accord. Grade 1-2 and grade 3 cytokine release syndrome occurred in 43.2% and 2.7% of patients, respectively. One patient experienced grade 3 neurotoxicity. The most common severe adverse events were hematological toxicities, including neutropenia (in 97.3% of patients), thrombocytopenia (in 40.5%), and anemia (in 43.2%). The adverse effects were comparable between the two groups. The best objective response rates were 84.6% vs. 66.7% (p > 0.05) in patients with and without BTKi, and the best complete response rates were 61.5% vs. 25.0% (p < 0.05). The combination of BTKi significantly prolonged the overall survival but did not affect the progression-free survival or the duration of response. T cells of patients treated with BTKi were predisposed to early differentiation and less exhaustion 3 months after CART19 infusion. Single-cell RNA sequencing analysis demonstrated that T cells were dysfunctional at relapse.

conclusionBTKi combined with CART19 induced better outcomes with good safety profiles in patients with BCL.

trial registrationClinicalTrials.gov identifier: NCT05020392.

Indexed as

Agammaglobulinaemia Tyrosine KinaseAntigens, CD19Immunotherapy, AdoptiveLymphoma, B-CellNeoplasm Recurrence, LocalProtein Kinase InhibitorsReceptors, Chimeric AntigenAdultAgedCytokine Release SyndromeFemaleHumansMaleMiddle AgedAgammaglobulinaemia Tyrosine KinaseAntigens, CD19BTK protein, humanCD19 molecule, humanProtein Kinase InhibitorsReceptors, Chimeric AntigenB‐cell lymphomaBruton tyrosine kinase inhibitorchimeric antigen receptor‐T cellpragmatic clinical trial

Identifiers

PMID41123227
PMCPMC12541673

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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.