Comparison of the safety profiles of CD19-targeting CAR T-cell therapy in patients with SLE and B-cell lymphoma

F Fabian Müller (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) N Nora Rebecca Schwingen (1Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany) M Melanie Hagen J Julia Katharina Scholz (1University Hospital of Erlangen, Department of Internal Medicine 5 - Hematology and Oncology, Erlangen, Germany) M Michael Aigner (Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany) A Andreas Wirsching (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) J Jule Taubmann (3Deutsches Zentrum Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany) S Sascha Kretschmann (Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany) S Soraya Kharboutli (Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany) T Tobias Krickau (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) N Nora Naumann-Bartsch (5Department of Pediatrics, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany) G Giulia Benintende (1Department of Internal Medicine 5 - Hematology & Oncology, University Hospital of Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, Medicine 5, Erlangen, Germany) S Silvia Spoerl (1Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine 5 – Hematology and Oncology, Erlangen, Germany) T Tobias Rothe (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) H Heiko Bruns (1Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany) R Ricardo Grieshaber-Bouyer M Markus Metzler (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) D David B. Blumenthal F Frederik Graw G Georg Schett (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) A Andreas Mackensen (Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany) S Simon Völkl (Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany)

Abstract

Abstract CD19-directed chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and recently showed effects in autoimmune diseases, such as systemic lupus erythematosus (SLE). Despite high levels of inflammation, toxicity seemed to differ between patients with SLE and B-NHL. We therefore compared the CAR T-cell kinetics and treatment-related side effects to better define the toxicity profiles. In contrast with the similar CAR T-cell expansion, patients with SLE revealed a lower incidence and severity of cytokine-release syndrome, immune effector cell–associated neurotoxicity syndrome, and immune effector cell–associated hematotoxicity. Although the neutrophil nadir was lower in patients with SLE after therapy, the platelet counts remained close to normal and hematotoxicity was shorter in SLE than B-NHL. The reduced hematotoxicity correlated with lower acute-phase inflammation, better hematologic reserve before CAR T-cell therapy, and distinct serum cytokine profiles. Interestingly, CAR T-cell persistence was consistently shorter, and the reconstitution of conventional T and B cells was faster in SLE. In both cohorts, B-cell reconstitution correlated with functional CD4+ T-cell recovery, indicating a general biologic process of hematopoietic and immune system regeneration. In summary, similar lymphodepletion and CAR T-cell pharmacokinetics led to distinct toxicity, demonstrating that CAR T-cell therapy had a favorable side-effect profile in SLE, including faster recovery of the adaptive immune system.

Article Details

Journal Blood
Volume / Issue Vol. 146, Issue 9
Published August 28, 2025
Pages 1088-1095
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (22)

F

Fabian Müller

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

N

Nora Rebecca Schwingen

1Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany

M

Melanie Hagen

J

Julia Katharina Scholz

1University Hospital of Erlangen, Department of Internal Medicine 5 - Hematology and Oncology, Erlangen, Germany

M

Michael Aigner

Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany

A

Andreas Wirsching

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

J

Jule Taubmann

3Deutsches Zentrum Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany

S

Sascha Kretschmann

Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany

S

Soraya Kharboutli

Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany

T

Tobias Krickau

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

N

Nora Naumann-Bartsch

5Department of Pediatrics, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany

G

Giulia Benintende

1Department of Internal Medicine 5 - Hematology & Oncology, University Hospital of Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, Medicine 5, Erlangen, Germany

S

Silvia Spoerl

1Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine 5 – Hematology and Oncology, Erlangen, Germany

T

Tobias Rothe

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

H

Heiko Bruns

1Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany

R

Ricardo Grieshaber-Bouyer

M

Markus Metzler

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

D

David B. Blumenthal

F

Frederik Graw

G

Georg Schett

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

A

Andreas Mackensen

Friedrich-Alexander-Universität Erlangen–Nürnberg, Erlangen, Germany

S

Simon Völkl

Friedrich-Alexander-University Erlangen–Nuremberg, Erlangen, Germany