Journal Article

DKFZ-2026-02623

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Extracorporeal photopheresis for the treatment of steroid-refractory immune related adverse events from immune checkpoint inhibitor therapy: a multi-center phase Ib/II clinical trial.

Riemer, R. ; Braun, L.DKFZ* ; Giesler, S. ; Rafei-Shamsabadi, D. ; Haferkamp, S. ; Hartmann, A. ; Melchinger, W. ; Weiss, M. ; Birth, S. ; Philipp, U. ; Gebhard, I. ; Schwänen, C. ; Hutchinson, J. A. ; Karantzelis, N. ; Wallrabenstein, T. ; Lowinus, T. ; Brehm, N. ; Rawluk, J. ; Pfeifer, D. ; Osswald, N. ; Bronsert, P. ; Rogg, M. ; Andreev, G. ; Börries, M.DKFZ* ; Lammer, M. ; Nguyen, V. A. ; Schmuth, M. ; Köhler, N. ; Duyster, J.DKFZ* ; Ihorst, G. ; Keye, P. ; Minguet, S. ; Schadendorf, D.DKFZ* ; Ugurel, S. ; Thimme, R. ; Hasselblatt, P. ; Pearce, E. L. ; Becher, B. ; Funke-Lorenz, C. ; Scherer, F. ; Bengsch, B.DKFZ* ; Schell, C. ; Placke, J.-M. ; Meiss, F. ; Apostolova, P.DKFZ* ; Zeiser, R.DKFZ*

2026
Springer Nature [London]

Abstract: Severe immune-related adverse events (irAE) in cancer patients receiving immune checkpoint inhibitors (ICI) require treatment interruption and immunosuppression. Based on prior preclinical data, in this prospective, single arm, non-randomized phase-Ib/II clinical trial we test the activity of Extracorporeal Photopheresis (ECP) against steroid-refractory irAEs in 30 patients (EudraCT-No.:2021-002073-26). The primary endpoint is the evaluation of the safety of ECP treatment for patients with ICI-induced irAEs. The study meets its pre-specified primary endpoint of less than 50% of patients developing ECP-related severe adverse events (SAE). No ECP-related SAE is observed and ECP-related AEs are reported in 20% (6/30) of patients. Overall response rate for all irAEs is 96.3% (CI 81.0-99.91). Colitis-, hepatitis- and dermatitis-specific response rates are 100% (13/13), 86.7% (13/15) and 100% (3/3), respectively. Secondary endpoints include the assessment of response rate of irAE and overall survival. ECP therapy is associated with reduced granzyme-A/B/K, T-bet, interferon-γ and TNF in peripheral T cells and pro-inflammatory gene-expression in the intestinal tract. The 12-month overall survival rate is 84.3% (CI 63.4%-93.8%). Response correlates with a decrease in inflammatory gene expression in the intestinal tract. These results suggest that ECP is a safe treatment option for SR-irAEs and warrant further investigation in subsequent randomized clinical trials.

Keyword(s): Humans (MeSH) ; Photopheresis: methods (MeSH) ; Photopheresis: adverse effects (MeSH) ; Immune Checkpoint Inhibitors: adverse effects (MeSH) ; Immune Checkpoint Inhibitors: therapeutic use (MeSH) ; Female (MeSH) ; Male (MeSH) ; Neoplasms: drug therapy (MeSH) ; Neoplasms: immunology (MeSH) ; Neoplasms: therapy (MeSH) ; Middle Aged (MeSH) ; Aged (MeSH) ; Adult (MeSH) ; Treatment Outcome (MeSH) ; Prospective Studies (MeSH) ; Steroids: therapeutic use (MeSH) ; Colitis: therapy (MeSH) ; Immune Checkpoint Inhibitors ; Steroids

Note: #DKTKZFB9# / #NCTZFB9#

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Freiburg (FR01)
2. DKTK Koordinierungsstelle Essen/Düsseldorf (ED01)
3. Koordinierungsstelle NCT West (WT01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2026

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; ; Article Processing Charges ; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Agriculture, Biology and Environmental Sciences ; Current Contents - Life Sciences ; Current Contents - Physical, Chemical and Earth Sciences ; DOAJ Seal ; Essential Science Indicators ; Fees ; IF >= 15 ; JCR ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection ; Zoological Record

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