Fraunhofer Institute for Cell Therapy and Immunology IZIFirst patient in LION-1 study receives immune cell therapy against new target molecule
The first patient was treated with a new CAR-T cell therapy as part of the LION-1 phase I clinical trial at the University Hospital of Würzburg.
The clinical investigational medicinal products are produced by the Fraunhofer IZI. In the modern clean rooms of the “GMP Cell and Gene Therapy” department, specific immune cells from the patient are first isolated and enriched. The genetic information for the novel CAR receptor against the surface antigen ROR1is then stably integrated into the genome of the T cells. The cells are then proliferated over several days. In contrast to all previously approved CAR-T cell therapies, the virus-free sleeping beauty transposon technology is used.
The therapeutic concept was developed at the University Hospital of Würzburg by a team led by Prof. Dr. Michael Hudecek. As part of a pilot project, pre-clinical studies to evaluate the safety and efficacy of the ROR1 CAR-T cells have already been carried out at the Fraunhofer IZI and the pharmaceutical production of the IMP has been established. Subsequently, the IMP was added to the existing manufacturing authorization in accordance with § 13 of the German Medicines Act.
- More information on the pharmaceutical production of the IMP (izi.fraunhofer.de)
