| 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. © 2022 Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: |
adult; cancer survival; clinical article; controlled study; aged; fludarabine; neutropenia; salvage therapy; phase 2 clinical trial; neoplasm recurrence, local; anemia; point-of-care systems; bleeding; thrombocytopenia; incidence; cohort analysis; bendamustine; cyclophosphamide; pathology; risk factor; febrile neutropenia; receptors, antigen, t-cell; tumor recurrence; remission; chimeric antigen receptor; lymphoma, large b-cell, diffuse; phase 1 clinical trial; corticosteroid; observational study; brain ischemia; point of care; disease exacerbation; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; lymphocyte antigen receptor; antigens, cd19; etiology; adverse event; leukapheresis; institutional review; erythema multiforme; point of care testing; diffuse large b cell lymphoma; tocilizumab; humans; human; male; female; article; car-t; tisagenlecleucel t; chimeric antigen receptor t-cell immunotherapy; point of care system; oos; production failure; tisa-cel
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