Evidence map›Paper›PMID 41501497›Full record

Trial reportNature medicine2026

CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial.

Fabian Müller, Melanie Hagen, Andreas Wirsching, Soraya Kharboutli, Michael Aigner, Simon Völkl, Sascha Kretschmann, Koray Tascilar, Jule Taubmann, Laura Bucci and 24 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06347718 (CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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.

NCT06347718 phase1 / phase2recruitingnot on this map

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

TypeinterventionalSponsorMiltenyi Biomedicine GmbHRan2023 to 2026Enrolled24ConditionsSystemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, PolymyositisArmsanti-CD19 CAR T cell therapy
3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

  1. Review
  2. Article
  3. Resetting immunometabolic set points in autoimmune disease.Journal of translational autoimmunity · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. New treatments in myositis on the horizon.EULAR rheumatology open · 2026
    Review
  9. T Cell Thoughts.Immunological reviews · 2026
    Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Defective B cell tolerance in SLE lymph nodes underpins VHmedRxiv : the preprint server for health sciences · 2026
    Article
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

34 authors.

Fabian Müller *Department of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0001-5487-5839
Melanie Hagen *Deutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Andreas Wirsching *Deutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Soraya KharboutliDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Michael AignerDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Simon VölklDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0003-2193-3048
Sascha KretschmannDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0001-8168-7542
Koray TascilarDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0002-8109-826X
Jule TaubmannDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Laura BucciDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Maria Gabriella RaimondoDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0003-2020-6711
Christina BergmannDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0001-5257-9171
Tobias RotheDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Giulia CorteDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Carlo TurDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0009-0003-6241-6116
Luis MuñozDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0002-5395-804X
Sebastian BöltzDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0001-5227-8707
Louis SchusterDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Fabian HartmannDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0001-6106-1657
Panagiotis GarantziotisDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Silvia SpörlDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Ingrid VasovaDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Armin GerbitzDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Bernd SpriewaldDepartment of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Hans KienerDepartment of Internal Medicine 3, Medical University of Vienna, Vienna, Austria.
Diana GiannarelliBiostatistical Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Franco LocatelliDepartment of Pediatric Hematology/Oncology and Cell & Gene Therapy, IRCCS Bambino Gesu Children's Hospital, Catholic University of the Sacred Heart, Rome, Italy.ORCID http://orcid.org/0000-0002-7976-3654
Maria-Antonietta D'AgostinoDepartment of Rheumatology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Linda HanssensMiltenyi Biomedicine, Bergisch Gladbach, Germany.
Stefan MiltenyiMiltenyi Biomedicine, Bergisch Gladbach, Germany.
Aline BozecDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Ricardo Grieshaber-BouyerDeutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0002-2873-5135
Andreas Mackensen *Department of Internal Medicine 5 - Hematology and Oncology, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0002-0685-4483
Georg Schett *Deutsches Zentrum Immuntherapie, Friedrich Alexander Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany. georg.schett@uk-erlangen.de.ORCID http://orcid.org/0000-0001-8740-9615

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chimeric antigen receptor (CAR)-T cells are considered a powerful therapeutic tool to reset the immune system in patients with autoimmune diseases. Innovative trial designs are needed to allow feasible testing of the safety and efficacy of CAR-T cells in clinical studies. CASTLE (CAR-T cells in systemic B cell mediated autoimmune disease) is a phase 1/2a two-stage optimal design basket study that investigated the safety and efficacy of zorpocabtagene autoleucel (Zorpo-cel, also known as MB-CART19.1), an autologous CD19 CAR-T cell product, in patients with treatment-resistant systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM). The primary safety outcome was the rate of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The secondary clinical efficacy outcomes were remission of SLE according to DORIS criteria, no progression of interstitial lung disease in SSc and American College of Rheumatology (ACR) major/moderate response in IIM after 24 weeks. A total of 24 patients were enrolled (10 with SLE, 9 with SSc and 5 with IIM), all receiving a single infusion of Zorpo-cel after stopping immunosuppressive treatments and receiving standard lymphodepletion with cyclophosphamide and fludarabine. Primary and secondary endpoints of CASTLE were met. Regarding safety, no CRS higher than grade 2 and no ICANS occurred. Regarding efficacy, 22 of the 24 patients achieved predefined efficacy endpoints, with 9 out of 10 patients with SLE reaching DORIS remission, 9 out of 9 patients with SSc showing no disease progression, and 4 out of 5 patients with IIM reaching ACR major/moderate response. Furthermore, all patients remained free of glucocorticoids and any other immunosuppressive treatment over the entire observation period of 24 weeks. CASTLE suggests the feasibility, safety and efficacy of Zorpo-cel in three different autoimmune diseases and paves the way for conducting a pivotal study. ClinicalTrials.gov identifier: NCT06347718 , EudraCT identifier: 2022-001366-35 .

Indexed as

Antigens, CD19Autoimmune DiseasesImmunotherapy, AdoptiveLupus Erythematosus, SystemicMyositisReceptors, Chimeric AntigenScleroderma, SystemicT-LymphocytesAdultCytokine Release SyndromeFemaleHumansMaleMiddle AgedReceptors, Antigen, T-CellTreatment OutcomeAntigens, CD19Receptors, Antigen, T-CellReceptors, Chimeric Antigen

Identifiers

PMID41501497
PMCPMC13004673

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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.