Clinical trial management

The clinical trial management platform oversees the delivery of the BRC’s portfolio of clinical trials. With the development of advanced cell and gene therapy trials, the platform provides significant experience and expertise in overseeing first-in-human and early phase clinical trials.  The platform undertakes the day-to-day operational management of clinical trials, preparing submissions to ethical and regulatory bodies, liaison with the suppliers of investigational medicinal products, working with database developers, data managers and trial statisticians to ensure systems and documentation are in place for data capture and analysis.

Example projects

  • The ThRIL trial (NCT02166177): A first-in-human advanced cell therapy to investigate whether T-regulatory cells can reduce the need for immunosuppression in liver transplant patients (Sánchez-Fueyo A, et al. (2020) Am J Transplant. 20(4):1125-1136).
  • The T4 trial (NCT XXXXX): A first-in-human advanced cell therapy with autologous CD28-based CAR-T cells to treat intractable head and neck cancer. Subjects have been treated with and without lymphodepletion.
  • The TRIBUTE trial (NCT XXXXX): A first-in-human advanced cell therapy to investigate whether autologous, enriched sub-population of naïve T-regulatory cells, reprogrammed to home to the gut, can treat Crohn’s Disease.
  • The HELP trial (NCT XXXXX): A first-in-human advanced cell therapy using donor liver cells encapsulated in alginate to act as a bridge to liver repair or liver transplant in children with acute liver failure.
  • The EMPIRIKAL2 trial (NCT XXXXX): A clinical trial to determine whether a novel recombinant protein, a CR1 analogue, is able to protect donor kidneys from damage during storage and thereby prevent rejection in the transplant recipient.
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