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

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

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.

SALVAGE therapy; T cells; CHIMERIC antigen receptors; INSTITUTIONAL review boards; POINT-of-care testing

Leukemia & Lymphoma, 2022, Vol 63, Issue 14, p3385

1042-8194

Academic Journal

10.1080/10428194.2022.2123232