Evidence map›Paper›PMID 34893603›Full record

ArticleNature communications2021

Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients.

Michael Maschan, Paolo F Caimi, Jane Reese-Koc, Gabriela Pacheco Sanchez, Ashish A Sharma, Olga Molostova, Larisa Shelikhova, Dmitriy Pershin, Alexey Stepanov, Yakov Muzalevskii and 17 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 3% 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.

NCT03434769 phase1active not recruitingnot on this map

Phase I Clinical Trial of AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non Hodgkin Lymphoma

TypeinterventionalSponsorBenjamin TomlinsonRan2018 to 2036Enrolled31ConditionsNon-Hodgkin LymphomaArmsCyclophosphamide, Fludarabine, CAR-T Cells
NCT03467256 phase1 / phase2unknown statusnot on this map

A Single-Arm Phase I/II Study Evaluating the Safety and Clinical Efficacy Of the 2-nd Generation CD19 Autologous CAR T Cells on the CliniMACS Prodigy Automated Manufacturing Platform in Treatment of Paediatric And Young Adult Patients With Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia

TypeinterventionalSponsorFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyRan2018 to 2025Enrolled18ConditionsB-cell Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, PediatricArmsChimeric Antigen Receptor T-Cell Therapy, Fludarabine, Cyclophosphamide, Tocilizumab, Cytarabine
NCT07502118 phase2 / phase3recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

TypeinterventionalSponsorHealth Institutes of TurkeyRan2025 to 2030Enrolled40ConditionsRelapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL)ArmsTalikabtagene Autoleucel
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Locally manufacturedHaematologica · 2026
    Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  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

27 authors at 8 institutions in 2 countries.

Michael Maschan *Dmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.ORCID 0000-0003-1735-0093
Paolo F Caimi *University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Jane Reese-KocUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Gabriela Pacheco SanchezEmory University, Atlanta, GA, USA.ORCID 0000-0002-0394-0589
Ashish A SharmaEmory University, Atlanta, GA, USA.ORCID 0000-0001-9444-7046
Olga MolostovaDmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.
Larisa ShelikhovaDmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.
Dmitriy PershinDmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.ORCID 0000-0002-6148-7209
Alexey StepanovDmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.ORCID 0000-0003-1616-4408
Yakov MuzalevskiiDmitriy Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation.ORCID 0000-0003-3513-8299
Vinicius G SuzartUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Folashade OtegbeyeUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
David WaldUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Ying XiongLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Darong WuLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Adam KnightLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Ibe OparaochaLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Beatrix FerenczLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Andre RoyLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.ORCID 0000-0002-9738-616X
Andrew WordenLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Winfried KrugerLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Michael KadanLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Dina SchneiderLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Rimas OrentasLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA.
Rafick-Pierre SekalyEmory University, Atlanta, GA, USA.
Marcos de LimaUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA. marcos.delima@osumc.edu.ORCID 0000-0002-8568-4522
Boro DropulićLentigen, A Miltenyi Biotec Company, Gaithersburg, MD, USA. boro.dropulic@caringcross.org.
Lentigen Technology (United States) · USDmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology · RUUniversity Hospitals Seidman Cancer Center · USEmory University · USCleveland Clinic · USInstitute of Bioorganic Chemistry · RUThe Ohio State University at Marion · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chimeric antigen receptor (CAR) T cells targeting the CD19 antigen are effective in treating adults and children with B-cell malignancies. Place-of-care manufacturing may improve performance and accessibility by obviating the need to cryopreserve and transport cells to centralized facilities. Here we develop an anti-CD19 CAR (CAR19) comprised of the 4-1BB co-stimulatory and TNFRSF19 transmembrane domains, showing anti-tumor efficacy in an in vivo xenograft lymphoma model. CAR19 T cells are manufactured under current good manufacturing practices (cGMP) at two disparate clinical sites, Moscow (Russia) and Cleveland (USA). The CAR19 T-cells is used to treat patients with relapsed/refractory pediatric B-cell Acute Lymphocytic Leukemia (ALL; n = 31) or adult B-cell Lymphoma (NHL; n = 23) in two independently conducted phase I clinical trials with safety as the primary outcome (NCT03467256 and NCT03434769, respectively). Probability of measurable residual disease-negative remission was also a primary outcome in the ALL study. Secondary outcomes include complete remission (CR) rates, overall survival and median duration of response. CR rates are 89% (ALL) and 73% (NHL). After a median follow-up of 17 months, one-year survival rate of ALL complete responders is 79.2% (95%CI 64.5‒97.2%) and median duration of response is 10.2 months. For NHL complete responders one-year survival is 92.9%, and median duration of response has not been reached. Place-of-care manufacturing produces consistent CAR-T cell products at multiple sites that are effective for the treatment of patients with B-cell malignancies.

Indexed as

AdolescentAdultAgedAnimalsAntigens, CD19B-LymphocytesChildChild, PreschoolFemaleHumansInfantLymphoma, B-CellMaleMiceMice, Inbred NODMiddle AgedAntigens, CD19CD19-specific chimeric antigen receptorReceptors, Antigen, T-CellReceptors, Chimeric AntigenReceptors, Tumor Necrosis FactorTNFRSF19 protein, human

Identifiers

PMID34893603
PMCPMC8664838
OpenAlexW4200414258

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.