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Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel.
Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel.
- Source :
-
Leukemia & lymphoma [Leuk Lymphoma] 2022 Dec; Vol. 63 (14), pp. 3385-3393. Date of Electronic Publication: 2022 Sep 16. - Publication Year :
- 2022
-
Abstract
- 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.
Details
- Language :
- English
- ISSN :
- 1029-2403
- Volume :
- 63
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- Leukemia & lymphoma
- Publication Type :
- Academic Journal
- Accession number :
- 36111694
- Full Text :
- https://doi.org/10.1080/10428194.2022.2123232