Publisher
Springer Science and Business Media LLC
Subject
Transplantation,Hematology
Reference12 articles.
1. Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, et al. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N. Engl J Med. 2019;380:45–56.
2. Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, et al. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22:1403–15.
3. Tyagarajan S, Spencer T, Smith J. Optimizing CAR-T cell manufacturing processes during pivotal clinical trials. Mol Ther Methods Clin Dev. 2020;16:136–44.
4. European Medicines Agency. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. 2017. 2017_11_22_guidelines_gmp_for_atmps_0.pdf (europa.eu) https://health.ec.europa.eu/system/files/2017-11/2017_11_22_guidelines_gmp_for_atmps_0.pdf.
5. Rossoff J, Baggott C, Prabhu S, Pacenta H, Phillips CL, Stefanski H, et al. Letter to Blood Out-of-specification tisagenlecleucel does not compromise safety or efficacy in pediatric acute lymphoblastic leukemia. Blood. 2021;138:2138–42.