Industry objects to unproven T-cell preservation services

Posted: 8 August 2019 | Rachael Harper (Drug Target Review) | No comments yet

ISCT, the International Society for Cell and Gene Therapy has announced its objection to linking the benefits of cellular immunotherapy, in particular, Chimeric Antigen Receptor (CAR) T-cell therapy, with recent market offerings for third party cryopreserving and banking of T cells for future therapeutic use. 

“Currently, companies are promising an undeliverable service,” said Bruce Levine, PhD, President-Elect, ISCT. “The commercial use of CAR-T cells employs the collection procedure of apheresis to remove billions of white blood cells for further processing. If and when a commercial product is developed in the future that could utilise as few cells as could be obtained from a small blood draw, there would be extensive quality and regulatory requirements for CAR-T therapy providers to use pre-stored T cells from a third party banking service.

“Marketing this service today as a prelude to a potential therapy in the future to cancer patients, and especially to healthy people, is misleading. As one of the inventors of CAR-T therapies… I find it highly unlikely that current commercial manufacturers would assent to using a third party bank of blood drawn cells in the near future.” 

1. CAR-T therapy has only been approved for a distinct subset of blood cancers. There is, therefore, a low probability of patients that acquire cancer actually being eligible for CAR-T therapy. There is an even lower probability that healthy people, even those with a relative with cancer, would one day be eligible for CAR-T therapy
2. The marketing and promotional materials by companies offering T-cell preservation services are currently misrepresentative of the practical use of the banked cells
3. There is currently no likelihood that a small blood draw of cells collected by third party banking services may be suitable for use by commercial manufacturers of CAR-T cell therapies. 

“Patients and members of the public need to have the right information available to make informed decisions on using services to preserve healthy T cells,” added Massimo Dominici, MD, Chair of the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapy, ISCT. “Without scientific validation, these companies are creating the ground for ‘frozen’ unproven cell and gene therapies, potentially generating disappointing and even harmful results for the field.”