GMP production of a virus-free gene-transfer vector for ROR1-specific CAR T-cells and immunotherapy of ROR1+ tumors

Institution: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg
Applicant: Prof. Dr. Michael Hudecek

Funding line:

Translational Research

The Sleeping Beauty transposon system is a DNA transposon, specifically engineered to insert DNA sequences into the chromosomes of vertebrate animals. Its objectives are to introduce novel traits or to explore genes and their functions.

Project partner:

Prof. Dr. med. Ulrike Köhl, Fraunhofer-Institut für Zelltherapie und Immunologie (IZI) Leipzig
Prof. Dr. med. Hermann Einsele. Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg

Project:

Univ.-Prof.Dr.med. Hudecek and his team are working on an innovative treatment option for cancer called ROR1-CAR-T cell therapy. This therapy bears the potential to target and fight solid tumors, which is not possible with current CAR-T cell therapies.

With the support of the ForTra gGmbH, the Würzburg team is able to produce special genetic material that is used for the production of the ROR1-CAR-T cell product. This material, a DNA vector, carries the genetic information that enables gene transfer into the ROR1-CAR-T cells. The vector can be manufactured in larger quantities in a short period of time, significantly improving the safety and scalability of CAR-T cell products compared to conventional viral vectors. This is intended to facilitate accessibility for patients to this innovative treatment option.

In a next step, the production of the ROR1-CAR-T cells under GMP conditions will be established in close cooperation with the Fraunhofer Institute for Cell Therapy and Immunology (IZI). Based on this cooperation, the best possible quality and efficacy of the cell product should be achieved while maintaining the highest quality standards.
The final cell product will be thoroughly evaluated in the LION-1 clinical trial to confirm the efficacy and safety of ROR1-CAR-T cell therapy in various cancer types. It is envisioned that the clinical trial will be conducted in collaboration with the National Center for Tumor Diseases (NCT), which is committed to advancing breakthrough research in cancer therapy. The study will enroll patients with various cancers, including breast cancer, ovarian cancer, adrenocortical cancer, thyroid cancer, chronic lymphocytic leukemia and mantle cell lymphoma. The goal is to make a significant advance in the treatment of cancer patients and provide them with a promising new therapeutic option. ROR1-CAR-T cell therapy has the potential to positively impact the lives of many patients.

Here you can find further information.

From left to right: Dr.rer.nat. Justus Weber, Dr.rer.nat. Katrin Mestermann, Prof.Dr.med. Michael Hudecek, PD Dr.rer.nat Thomas Nerreter, Dr.rer.nat Julia Beckmann.

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