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Preservation of CD4+ CD8+ central memory cells in Prodigy Expanded CAR-T Line.
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Context 1
... of the G-Rex resulted in a greater total cell expansion. Populations of central and effector memory T cells were similar in both Prodigy and manually made CAR-T cells (Figure 1). Conclusions: CAR-T cells generated by the Prodigy are similar in phenotype and function to those prepared using manual methods. ...
Citations
... The starting material for car-t manufacturing comes from the patient. Protocol requirements can vary, but a circulating CD3 count of at least 150/mm 3 is generally needed to reliably collect a number of T cells sufficient for manufacturing 7,8 . Some products are manufactured with freshly collected cells; others start with frozen product. ...
Adoptive cellular therapy with chimeric antigen receptor T cells (car-ts) has recently received approval from Health Canada and the U.S. Food and Drug Administration after remarkable and durable remissions were seen in children with recurrent or refractory leukemia and adults with non-Hodgkin lymphoma-responses that were so impressive that a shift in the paradigm of care has now occurred for children with acute lymphoblastic leukemia. The concept behind car-t immunotherapy is that modification of a patient's own T cells to facilitate their localization to the cancer cell, with subsequent activation of the T cell effector mechanism and proliferation, will result in targeted killing of cancer cells. The car-ts are a novel drug in that the starting material for the manufacture of the car-t product comes from the patient, whose viable T cells are then genetically modified. Thus, collaboration is needed between the pharmaceutical companies, which must meet good manufacturing standards for each patient's unique product, and the treating sites. For regulators and health authorities, this new class of drugs requires new paradigms for assessment and approval. Treatments with car-ts require that institutions address unique logistics requirements and management of novel toxicities. The Hospital for Sick Children has had early experience with both the licensing of clinical trials and the introduction of the first commercial product. Here, we provide an overview of basic concepts and treatment, with caveats drawn from what we have learned thus far in bringing this new therapy to the clinical front line.
