Evidence map›Paper›PMID 32608579›Full record

Trial reportCancer medicine2020

Phase II trial of co-administration of CD19- and CD20-targeted chimeric antigen receptor T cells for relapsed and refractory diffuse large B cell lymphoma.

Wei Sang, Ming Shi, Jingjing Yang, Jiang Cao, Linyan Xu, Dongmei Yan, Meixue Yao, Hui Liu, Weidong Li, Bing Zhang and 19 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03207178 (Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor), which is not on this map. Cited by 54 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 11 pooled it
–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.

NCT03207178 phase1 / phase2unknown statusnot on this map

Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma

TypeinterventionalSponsorShanghai Longyao Biotechnology Inc., Ltd.Ran2017 to 2020Enrolled20ConditionsRecurrent or Refractory B Cell MalignancyArmsMixed CD19/CD20 CAR-T Transfer
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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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

29 authors.

Wei SangDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.ORCID 0000-0002-1170-7074
Ming ShiCancer Institute, Xuzhou Medical University, Xuzhou, China.
Jingjing YangDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Jiang CaoBlood Diseases Institute, Xuzhou Medical University, Xuzhou, China.
Linyan XuBlood Diseases Institute, Xuzhou Medical University, Xuzhou, China.
Dongmei YanDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Meixue YaoDepartment of Epidemiology and Biostatistics, School of Public Health, Xuzhou Medical University, Xuzhou, China.
Hui LiuDepartment of Pathology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Weidong LiDepartment of Radiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Bing ZhangDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Kemeng SunDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Xuguang SongDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Cai SunDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Jun JiaoDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Yuanyuan QinDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Tingting SangBlood Diseases Institute, Xuzhou Medical University, Xuzhou, China.
Yuanyuan MaDepartment of Pathology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Mei WuDepartment of Pathology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Xiang GaoDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Hai ChengDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Zhiling YanDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Depeng LiDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Haiying SunDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Feng ZhuDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Ying WangDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Lingyu ZengBlood Diseases Institute, Xuzhou Medical University, Xuzhou, China.
Zhenyu LiDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Junnian ZhengCancer Institute, Xuzhou Medical University, Xuzhou, China.
Kailin XuDepartment of Hematology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.ORCID 0000-0003-1375-1084

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAnti-CD19 chimeric antigen receptor T (CAR-T) cell therapy has demonstrated remarkable efficacy for refractory and relapsed diffuse large B cell lymphoma (R/R DLBCL). However, this therapy failed in nearly 25% patients mainly due to antigen loss. The authors performed a phase Ⅱ trial by coadministration of anti-CD19 and anti-CD20 CAR-T cells treatment for R/R DLBCL and evaluated its efficacy and toxicity.

methodsTotally 21 patients with DLBCL were enrolled in this study. The patients were conditioned with fludarabine and cyclophosphamide before the infusion of anti-CD19 and anti-CD20 CAR-T cells. Treatment response, toxicity, and persistence were monitored continuously.

resultsOf the 21 patients received the treatment, the objective response rate (ORR) is 81.0% (95% confidence interval [CI], 58.1%-94.6%) with four cases of bulk (4/5) and one case of testis involvement; 52.4% (95% CI, 29.8%-74.3%) had a complete response (CR). Peak levels of anti-CD19 and anti-CD20 CAR cells were associated with response (P = .007 and .002). Grade 3-4 cytokine release syndrome (CRS) and neurologic events occurred in 28.5% and 9.5% patients, respectively. Median overall survival (OS) and progression-free survival (PFS) were 8.1 and 5.0 months, respectively. The maximum standard uptake value (SUVmax) of CD4/CD8 ratio before and after infusion were associated with responses, and the total lesion glycolysis (TLG) before infusion correlates with cytokines level.

conclusionsCoadministration of anti-CD19 and CD20 CAR-T cells therapy for DLBCL is feasible with manageable toxicity. Cytokine markers are related to toxicity and SUVmax could predict efficacy. This trial was registered at www.clinicaltrials.gov as NCT03207178.

Indexed as

Antigens, CD19Antigens, CD20AdultAgedAnemiaAntineoplastic AgentsB-LymphocytesCD4-CD8 RatioConfidence IntervalsCyclophosphamideCytokine Release SyndromeFemaleGlycolysisHumansIfosfamideImmunotherapy, AdoptiveAntigens, CD19Antigens, CD20Antineoplastic AgentsCD19 molecule, humanCyclophosphamidefludarabineIfosfamideReceptors, Chimeric AntigenVidarabineCAR-TCD19CD20clinical trialDLBCL

Identifiers

PMID32608579
PMCPMC7433814

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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.