Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel

Shalev Fried, Roni Shouval, Nira Varda-Bloom, Michal J. Besser, Ronit Yerushalmi, Noga Shem-Tov, Ivetta Danylesko, Elad Jacoby, Shlomit Teihman, Orit Itzhaki, Joshua A. Fein, Meirav Kedmi, Avichai Shimoni, Arnon Nagler, Abraham Avigdor

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Tisagenlecleucel (tisa-cel) is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for patients with relapsed/refractory large B-cell lymphoma. Outcomes of patients with out-of-commercial specification (OOS) CAR T products are not well characterized. We therefore assessed 37 adult patients who underwent leukapheresis for tisa-cel therapy in a single center. In nine (24%) patients, manufactured tisa-cel was considered OOS. Three of them (33%) received tisa-cel after institutional review board approval; 2/9 (22%) did not receive tisa-cel due to disease progression; and 4/9 (44%) received academic point-of-care (POC) CAR T-cell as salvage therapy, at a median of 35 days following OOS notification. Three of those four patients achieved a complete response. In univariate analysis, risk factors for OOS were ≥ 4 prior therapies or previous bendamustine exposure. In conclusion, we report high OOS incidence of 24% in real-life setting. Forty-four percent of those patients received POC CAR T-cell as salvage therapy.

Original languageEnglish
Pages (from-to)3385-3393
Number of pages9
JournalLeukemia and Lymphoma
Issue number14
StatePublished - Dec 2022

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  • CAR-T
  • Chimeric antigen receptor
  • OOS
  • Tisa-cel
  • point of care
  • production failure


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