26 March, 2020
CAR-T Production Clinical Trial (Advanced Therapies)
CREATIO CONTRIBUTES TO THE SUCCESSFUL PRODUCTION OF CAR-T CELLS USED IN CLINICAL TRIAL AGAINST BLOOD CANCER
Since its inception in 2016, the ARI project (Assistance Research Intensive) led by the Hospital Clinic of Barcelona has received the support and the contribution of Creatio.
The ARI project, born from the dream of Ari Benedé – a girl diagnosed with acute lymphoblastic leukemia who passed on September 2, 2016 – grew into a full development project for an innovative immunotherapy strategy using CAR-T cells engineered to target blood cancer. This therapeutic strategy uses the patient’s own immune T cells and redirect their cytotoxicity by genetically modifying them to express a chimeric antigen receptor (CAR) against the cancer cells. The genetic modification can be achieved by infecting the T cells with lentiviral particles containing the genetic information coding for the CAR and this is where Creatio intervened. With its state-of-the-art facilities and expert staff, Creatio has been responsible for the production of the lentiviral particles at clinical grade for the ARI project. The particles were then used to infect the T cells previously extracted and selected from the 28 patients enrolled in the clinical trial in a semi-automatic closed system at the point-of-care. As such, each CAR-T cell preparation is a unique product made for a unique patient. The results of the whole production process and characterization of the 28 CAR-T cell products have just been published in Frontiers in Immunology by the Hospital Clinic team led by Dr. Manel Juan with co-authorship by Creatio’s scientists. The study shows that CAR T-cell manufacturing can be completed in a limited amount of time which improves the quality of the product and its persistence in patients after transplantation. In addition, the transduction efficiency of the lentiviral particles was shown to be in a very good range for both healthy controls and patients. Further, the produced CAR-T cells showed an appropriate phenotypic distribution and potent antitumor efficacy. The results of the trial have been very promising so far and are still collected, they will be published in the near future. Creatio is enthusiastic about the results and is confident that, after decades of efforts, exciting times are coming for a new breed of medicines encompassing cells, genes and tissues, now all grouped under the umbrella known as Advanced Therapies Medicinal Products (ATMP). Creatio’s expertise in clinical-grade lentiviral particle production is offered to the research community to thrive towards the future of medicine.