6/7/2023 0 Comments Texmacs media![]() CAR T cells in trials: recent achievements and challenges that remain in the production of modified T cells for clinical applications. Köhl U, Arsenieva S, Holzinger A, Abken H. Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. 2008 118:294–305.įraietta JA, Lacey SF, Orlando EJ, Pruteanu-Malinici I, Gohil M, Lundh S, et al. Adoptive transfer of effector CD8+ T cells derived from central memory cells establishes persistent T cell memory in primates. 2015 7:273ra13.īerger C, Jensen MC, Lansdorp PM, Gough M, Elliott C, Riddell SR. In vivo tracking of T cells in humans unveils decade-long survival and activity of genetically modified T memory stem cells. 2011 17:1290–7.īiasco L, Scala S, Basso Ricci L, Dionisio F, Baricordi C, Calabria A, et al. A human memory T cell subset with stem cell-like properties. Gattinoni L, Lugli E, Ji Y, Pos Z, Paulos CM, Quigley MF, et al. Automated manufacturing of potent CD20-directed chimeric antigen receptor T cells for clinical use. Lock D, Mockel-Tenbrinck N, Drechsel K, Barth C, Mauer D, Schaser T, et al. Prophylactic tocilizumab prior to anti-CD19 CAR-T cell therapy for non-hodgkin lymphoma. 2021 12:7200.Ĭaimi PF, Pacheco Sanchez G, Sharma A, Otegbeye F, Ahmed N, Rojas P, et al. Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients. Maschan M, Caimi PF, Reese-Koc J, Sanchez GP, Sharma AA, Molostova O, et al. Cost of decentralized CAR T-cell production in an academic nonprofit setting. Ran T, Eichmüller SB, Schmidt P, Schlander M. Closed-system manufacturing of CD19 and dual-targeted CD20/19 chimeric antigen receptor T cells using the CliniMACS Prodigy device at an academic medical center. Zhu F, Shah N, Xu H, Schneider D, Orentas R, Dropulic B, et al. Automated manufacture of autologous CD19 CAR-T cells for treatment of non-hodgkin lymphoma. ![]() Jackson Z, Roe A, Sharma AA, Lopes FBTP, Talla A, Kleinsorge-Block S, et al. Acute myeloid leukaemia: challenges and real world data from India. Philip C, George B, Ganapule A, Korula A, Jain P, Alex AA, et al. Financial toxicity and implications for cancer care in the era of molecular and immune therapies. No free rides: management of toxicities of novel immunotherapies in ALL, including financial. Our data highlights the safety, efficacy, and reproducibility of the process for use in planned future clinical trials. Based on our analysis, the cost per product would be approximately $35,107 US dollars. Evaluation of production costs in an academic, not for profit setting in India provide a benchmark for low and middle-income pricing which could greatly increase access to this therapy. The median transduction efficiency was 48.8%, with a median viability of 98% and fulfillment of all standard release criteria assays for clinical application. Validation run data, as part of a pre-clinical trial safety evaluation, demonstrates the successful and robust manufacturing of anti-CD19 CAR-T cells with T cell expansion of 25 to 47-fold. ![]() Here we demonstrate a decentralized manufacturing process for anti-CD19-CAR-T cells using a fully automated closed system (Miltenyi CliniMACS Prodigy®) is feasible in a developing country setting. Decentralized or point of care manufacturing has the potential to overcome some of these challenges. However, the high cost of existing industry-driven centralized production makes this therapy unaffordable in low and middle-income countries. Chimeric Antigen Receptor (CAR) T cell therapy is an accepted standard of care for relapsed/refractory B cell malignancies.
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