Evidence map›Paper›PMID 39386211›Full record

ArticleFrontiers in immunology2024

Automated manufacturing and characterization of clinical grade autologous CD20 CAR T cells for the treatment of patients with stage III/IV melanoma.

Krasimira Aleksandrova, Jana Leise, Christoph Priesner, Murat Aktas, Michael Apel, Mario Assenmacher, Iris Bürger, Anne Richter, Pia Altefrohne, Christine Schubert and 11 more

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

Article in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03893019 (Multicenter Phase I Trial of MB-CART20.1 for the Treatment of Patients With Metastatic Melanoma), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

NCT03893019 early_phase1terminatednot on this map

Multicenter Phase I Trial of MB-CART20.1 for the Treatment of Patients With Metastatic Melanoma

TypeinterventionalSponsorMiltenyi Biomedicine GmbHRan2019 to 2023Enrolled9ConditionsMelanoma (Skin)ArmsMB-CART20.1
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Cell Death Modalities in Therapy of Melanoma.International journal of molecular sciences · 2025
    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

21 authors.

Krasimira AleksandrovaInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Jana LeiseInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Christoph PriesnerInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Murat AktasMiltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany.
Michael ApelMiltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany.
Mario AssenmacherMiltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany.
Iris BürgerMiltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany.
Anne RichterMiltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany.
Pia AltefrohneMiltenyi Biomedicine GmbH, Bergisch Gladbach, Germany.
Christine SchubertMiltenyi Biomedicine GmbH, Bergisch Gladbach, Germany.
Astrid HolzingerDivision of Genetic Immunotherapy, Leibniz Institute for Immunotherapy (LIT) and University of Regensburg, Regensburg, Germany.
Markus BardenDivision of Genetic Immunotherapy, Leibniz Institute for Immunotherapy (LIT) and University of Regensburg, Regensburg, Germany.
Valerie BezlerDivision of Genetic Immunotherapy, Leibniz Institute for Immunotherapy (LIT) and University of Regensburg, Regensburg, Germany.
Michael von Bergwelt-BaildonMedical Department III, Hospital of the Ludwig Maximillian University of Munich (LMU), Munich, Germany.
Peter BorchmannInternal Medicine, University Hospital Cologne, Cologne, Germany.
Lilia GoudevaInstitute of Transfusion Medicine and Transplant Engineering (ITMTE), Hannover Medical School, Hannover, Germany.
Wolfgang GlienkeInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Lubomir ArsenievInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Ruth EsserInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.
Hinrich AbkenDivision of Genetic Immunotherapy, Leibniz Institute for Immunotherapy (LIT) and University of Regensburg, Regensburg, Germany.
Ulrike KoehlInstitute of Cellular Therapeutics (ICT), Hannover Medical School (MHH), Hanover, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Point-of-care (POC) manufacturing of chimeric antigen receptor (CAR) modified T cell has expanded rapidly over the last decade. In addition to the use of CD19 CAR T cells for hematological diseases, there is a growing interest in targeting a variety of tumor-associated epitopes. Methods: Here, we report the manufacturing and characterization of autologous anti-CD20 CAR T cells from melanoma patients within phase I clinical trial (NCT03893019). Using a second-generation lentiviral vector for the production of the CD20 CAR T cells on the CliniMACS Prodigy®. Results: We demonstrated consistency in cell composition and functionality of the products manufactured at two different production sites. The T cell purity was >98.5%, a CD4/CD8 ratio between 2.5 and 5.5 and transduction rate between 34% and 61% on day 12 (harvest). Median expansion rate was 53-fold (range, 42-65-fold) with 1.7-3.8×10 Discussion: In conclusion, the CliniMACS Prodigy® platform is well suited for decentralized POC manufacturing of anti-CD20 CAR T cells and may be likewise applicable for the rapid and automated manufacturing of CAR T cells directed against other targets. Clinical trial registration: https://clinicaltrials.gov/study/NCT03893019?cond=Melanoma&term=NCT03893019&rank=1, identifier NCT03893019.

Indexed as

Antigens, CD20Immunotherapy, AdoptiveMelanomaReceptors, Chimeric AntigenHumansMaleNeoplasm StagingT-LymphocytesAntigens, CD20Receptors, Chimeric Antigenautomated manufacturing of engineered T cell productsCD20 CAR investigational medicinal productcell composition of CAR T cell productsclinical CD20 CAR T cell trialex vivo expansion

Identifiers

PMID39386211
PMCPMC11461191

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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.