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Stock, S.* ; Bücklein, V.L.* ; Blumenberg, V.* ; Magno, G.* ; Emhardt, A.J.* ; Holzem, A.M.E.* ; Cordas Dos Santos, D.M.* ; Schmidt, C.* ; Grießhammer, S.* ; Frölich, L.* ; Kobold, S. ; von Bergwelt-Baildon, M.* ; Rejeski, K.* ; Subklewe, M.*

Prognostic significance of immune reconstitution following CD19 CAR T-cell therapy for relapsed/refractory B-cell lymphoma.

Hemasphere 9:e70062 (2025)

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Immune deficits after CD19 chimeric antigen receptor (CAR) T-cell therapy can be long-lasting, predisposing patients to infections and non-relapse mortality. In B-cell non-Hodgkin lymphoma (B-NHL), the prognostic impact of immune reconstitution (IR) remains ill-defined, and detailed cross-product comparisons have not been performed to date. In this retrospective observational study, we longitudinally characterized lymphocyte subsets and immunoglobulin levels in 105 B-NHL patients to assess patterns of immune recovery arising after CD19 CAR-T. Three key IR criteria were defined as CD4⁺ T helper (T_H) cells > 200/µL, any detectable B cells, and serum immunoglobulin G (IgG) levels >4 g/L. After a median follow-up of 24.6 months, 38% of patients displayed T_H cells, 11% showed any B cells, and 41% had IgG recovery. Notable product-specific differences emerged, including deeper T_H cell aplasia with CD28z- versus longer B-cell aplasia with 41BBz-based products. Patients with any IR recovery experienced extended progression-free survival (PFS) (median 20.8 vs. 1.7 months, p < 0.0001) and overall survival (OS) (34.9 vs. 4.0 months, p < 0.0001). While landmark analysis at 90 days confirmed improved PFS in patients with any recovery (34.9 vs. 8.6 months, p = 0.005), no significant OS difference was noted. Notably, 72% of patients with refractory disease never displayed recovery of any IR criteria. Early progressors showed diminished IR at the time of progression/relapse compared to patients with late progression/recurrence (after Day 90). Our results highlight the profound immune deficits observed after CD19 CAR-T and shed light on the intersection of IR and efficacy in B-NHL. Importantly, IR was impaired considerably postprogression, carrying significant implications for subsequent T-cell-engaging therapies and treatment sequencing.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Non-hodgkin-lymphoma; Infectious Complications; Axicabtagene Ciloleucel; Outcomes; Disease

ISSN (print) / ISBN 2572-9241

e-ISSN 2572-9241

Journal Hemasphere

Quellenangaben Volume: 9, Issue: 1, Article Number: e70062

Publisher Wolters Kluwer Health

Publishing Place 111 River St, Hoboken 07030-5774, Nj Usa

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Unit for Clinical Pharmacology (KKG-EKLiP)

Grants Else Kroner- Fresenius-Stiftung
Else-Kroner-Fresenius Stiftung
Wilhelm-Sander Stiftung
Bavarian Elite Graduate Training Network
DFG
Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)
Bruno and Helene Joster Foundation
Gilead Research Scholar Program
Forderprogramm fir Forschung und Lehre (FoFoLe) of the Medical Faculty of the LMU Munich
Novartis InCa Forderpreis 2022 for young researchers
DKTK School of Oncology
The "CAR-T Control" translational group within the Bavarian Center for Cancer Research (BZKF)