Chimeric Antigen Receptor-T (CAR-T) Cells as “Living Drugs”: A Clinical Pharmacist Perspective

Figure 3

CAR-T cell treatment cycle. The “vein-to-vein” process of CAR-T therapy is complex and lengthy. (a) Once the patient meets selection criteria and patient consent is obtained, clinical staff send a consent form and cell collection request form to the stem cell lab and apheresis unit and the manufacturer is notified. A blood sample from the patient or donor must be tested for infectious diseases and a precount of their cell composition is performed. Once all conditions are met, harvesting begins. The patient undergoes leukapheresis and the starting material is directly sent fresh to the manufacturing facility or sent to the stem cell lab to be cryopreserved and shipped to the manufacturer. (b) The CAR-T cells are manipulated by genomic transduction and expanded in a culture medium and formulated into the final product. The final product undergoes QC/QA tests, is released by a Qualified Person (QP), and is cryopreserved and sent to the stem cell lab to be verified and stored and released upon receipt of the product form. (c) During the time required for bioprocessing, the patient is being prepared to receive the CAR-T cells with bridging chemotherapy, to ensure minimal tumour burden if required, and lymphodepletion prior to anticipated infusion of the final product. (d) In the treatment centre, the ATMP pharmacist or Qualified Person from blood bank or the cell processing centre receives the product, verifies it, and issues the product for infusion. The product is thawed and infused. The patient is monitored for 10+ days and supportive care and toxicity management are issued with patient follow-up postinfusion. Key: CAR = chimeric antigen receptor.