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

References

• Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800–1808.
   PubMed Web of Science ®Google Scholar
• Schuster SJ, Bishop MR, Tam CS, JULIET Investigators, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):45–56.
   PubMed Web of Science ®Google Scholar
• Landsburg DJ, Frigault MJ, Hu Z-H, et al. Real-world efficacy and safety outcomes for patients with relapsed or refractory (R/R) aggressive B-cell non-Hodgkin’s lymphoma (aBNHL) treated with commercial tisagenlecleucel: update from the center for international blood and marrow transplant research (CIBMTR) registry. Blood. 2021;138(Suppl 1):429–429.
   Google Scholar
• Sesques P, Ferrant E, Safar V, et al. Commercial anti-CD19 CAR T cell therapy for patients with relapsed/refractory aggressive B cell lymphoma in a European center. Am J Hematol. 2020;95(11):1324–1333.
   PubMed Web of Science ®Google Scholar
• Pasquini MC, Hu Z-H, Curran K, et al. Real-world evidence of tisagenlecleucel for pediatric acute lymphoblastic leukemia and non-Hodgkin lymphoma. Blood Adv. 2020;4(21):5414–5424.
   PubMed Web of Science ®Google Scholar
• Iacoboni G, Villacampa G, Martinez-Cibrian N, GETH, GELTAMO Spanish Groups, et al. Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. Cancer Med. 2021;10(10):3214–3223.
   PubMed Web of Science ®Google Scholar
• Schuster SJ, Tam CS, Borchmann P, 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(10):1403–1415.
   PubMed Web of Science ®Google Scholar
• Chong EA, Gerson JN, Landsburg DJ, et al. Outcomes in aggressive B-cell non-Hodgkin lymphomas with anti-CD19 CAR T-cell (CTL019) products not meeting commercial release specifications. Blood. 2019;134(Suppl_1):594–594.
   Google Scholar
• Chong EA, Levine BL, Grupp SA, et al. CAR T cell viability release testing and clinical outcomes: is there a lower limit? Blood. 2019;134(21):1873–1875.
   PubMed Web of Science ®Google Scholar
• Kedmi M, Shouval R, Fried S, et al. Point-of-care anti-CD19 CAR T-cells for treatment of relapsed and refractory aggressive B-cell lymphoma. Transplant Cell Ther. 2022;28(5):251–257.
   PubMedGoogle Scholar
• Maschan M, Caimi PF, Reese-Koc J, et al. Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients. Nat Commun. 2021;12(1):7200.
   PubMed Web of Science ®Google Scholar
• Rossoff J, Baggott C, Prabhu S, et al. Out-of-specification tisagenlecleucel does not compromise safety or efficacy in pediatric acute lymphoblastic leukemia. Blood. 2021;138(21):2138–2142.
   PubMed Web of Science ®Google Scholar
• Itzhaki O, Jacoby E, Nissani A, et al. Head-to-head comparison of in-house produced CD19 CAR-T cell in ALL and NHL patients. J Immunother Cancer. 2020;8(1):e000148.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059–3068.
   PubMed Web of Science ®Google Scholar
• Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant. 2019;25(4):625–638.
   PubMed Web of Science ®Google Scholar
• Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996;17(4):343–346.
   PubMedGoogle Scholar
• Riedell PA, Brower J, Nastoupil L, et al. A multicenter analysis of outcomes, toxicities, and patterns of use with commercial axicabtagene ciloleucel and tisagenlecleucel for relapsed/refractory aggressive B-cell lymphomas. Blood. 2021;138(Supplement 1):2512–2512.
   Google Scholar
• Martínez-Calle N, Hartley S, Ahearne M, et al. Kinetics of T-cell subset reconstitution following treatment with bendamustine and rituximab for low-grade lymphoproliferative disease: a population-based analysis. Br J Haematol. 2019;184:957–968.
   PubMed Web of Science ®Google Scholar
• Burchardt A, Barth J, Rummel M, et al. Immunochemotherapy with bendamustine-rituximab (BR) as induction therapy for indolent lymphomas results in a severe lymphopenia with low CD4+ and CD8+ counts without an increase in atypical infections. First reports of the infectious disease (ID) project. Hematol Oncol. 2013;31:106.
   Google Scholar
• Hiddemann W, Barbui AM, Canales MA, et al. Immunochemotherapy with obinutuzumab or rituximab for previously untreated follicular lymphoma in the GALLIUM study: influence of chemotherapy on efficacy and safety. J Clin Oncol. 2018;36(23):2395–2404.
   PubMed Web of Science ®Google Scholar
• García Muñoz R, Izquierdo-Gil A, Muñoz A, et al. Lymphocyte recovery is impaired in patients with chronic lymphocytic leukemia and indolent non-Hodgkin lymphomas treated with bendamustine plus rituximab. Ann Hematol. 2014;93(11):1879–1887.
   PubMed Web of Science ®Google Scholar
• Duell J, Lukic DS, Karg M, et al. Functionally defective T cells after chemotherapy of B-cell malignancies can be activated by the tetravalent bispecific CD19/CD3 antibody AFM11. J Immunother. 2019;42(5):180–188.
   PubMed Web of Science ®Google Scholar
• Hosoda T, Yokoyama A, Yoneda M, et al. Bendamustine can severely impair T-cell immunity against cytomegalovirus. Leuk Lymphoma. 2013;54(6):1327–1328.
   PubMed Web of Science ®Google Scholar