Evidence map›Paper›PMID 41408297›Full record

ArticleJournal of translational medicine2025

Automated GMP-compatible production of universal CAR Tregs for organ-targeted tolerance induction.

Kavitha Lakshmi, Alexandra von Jutrzenka-Trzebiatowski, Liliana Loureiro, Karla Elizabeth González Soto, Katja Peter, José Manuel Marín Morales, Samikshya Santosh Nirmala, Nicole Berndt, Claudia Arndt, Yueyuan Hu and 12 more

Abstract read
In one paragraph

Article in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

22 authors.

Kavitha Lakshmi *Center for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Alexandra von Jutrzenka-Trzebiatowski *Helmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Liliana LoureiroHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Karla Elizabeth González SotoHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Katja PeterHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
José Manuel Marín MoralesCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Samikshya Santosh NirmalaCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Nicole BerndtHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Claudia ArndtMildred Scheel Early Career Center, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Yueyuan HuCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Jing-Wun LiCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Claudia PeitzschCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Anna TaubenbergerMildred Scheel Early Career Center, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Rebekka WehnerNational Center for Tumor Diseases (NCT), NCT/UCC Dresden, a Partnership Between DKFZ, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology and Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Heidelberg, Germany.
Marc SchmitzNational Center for Tumor Diseases (NCT), NCT/UCC Dresden, a Partnership Between DKFZ, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology and Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Heidelberg, Germany.
Kristina HöligInstitute for Transfusion Medicine, German Red Cross Blood Donation Service North-East, Dresden, Germany.
Hinrich AbkenDivision for Genetic Immunotherapy, Leibniz Institute for Immunotherapy (LIT), Regensburg, Germany.
Ezio BonifacioCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany.
Martin BornhäuserNational Center for Tumor Diseases (NCT), NCT/UCC Dresden, a Partnership Between DKFZ, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology and Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Heidelberg, Germany.
Michael BachmannHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Anja FeldmannHelmholtz-Zentrum Dresden-Rossendorf, Institute of Radiopharmaceutical Cancer Research, Dresden, Germany.
Anke FuchsCenter for Regenerative Therapies Dresden (CRTD), Center for Molecular and Cellular Bioengineering (CMCB), TUD Dresden University of Technology, Dresden, Germany. Anke.Fuchs1@tu-dresden.de.ORCID 0000-0003-3028-0827

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdoptive transfer of regulatory T cells (Tregs) has demonstrated safety, feasibility and early signs of efficacy in promoting immunological tolerance in inflammatory conditions such as graft-versus-host disease (GvHD). Chimeric antigen receptor (CAR)-engineered Tregs offer localized activation and suppression compared to polyclonal Tregs, but their clinical translation is limited by high manufacturing costs, lengthy developing times and fixed single-antigen specificity. To address these limitations, we employed the universal adapter Reverse CAR (RevCAR) system, which harbors a peptide epitope lacking intrinsic antigen specificity but provides flexibility in targeting through the use of an antigen-specific RevCAR Target Module (RevTM). As a proof-of-concept, we used a RevTM targeting carcinoembryonic antigen (CEA), which is highly expressed in the gastrointestinal (GI) tract, as a potential strategy to achieve localized immunosuppression in GI acute GvHD.

methodsTo support clinical translation, we established an automated, GMP-compatible, clinical-scale manufacturing process. Tregs were magnetically enriched from leukapheresis using the CliniMACS

resultsAcross five manufacturing runs, Tregs (CD4

conclusionThe study establishes a scalable, GMP-compatible process for manufacturing pure, stable and functional universal RevCAR Tregs for clinical applications. Furthermore, the RevCAR system offers a promising approach toward an allogenic, off-the-shelf Treg therapy capable of treating diverse immune-mediated diseases with spatial precision.

Indexed as

Immune ToleranceOrgan SpecificityReceptors, Chimeric AntigenT-Lymphocytes, RegulatoryAutomationCarcinoembryonic AntigenGraft vs Host DiseaseHumansCarcinoembryonic AntigenReceptors, Chimeric AntigenAutomated expansionClosed-system manufacturingGood manufacturing practicePrecision immunotherapyRegulatory T cellsTreg cell therapyUniversal adapter CAR

Identifiers

PMID41408297
PMCPMC12709696

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Registered trials

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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.