3-Laser Flow cytometer

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In the context of a new appointment we plan to further expand our “Cell Therapy” program by several new activities. We wish to build preclinical research and initiate, based on this research program, clinical phase I/II trials. The already existing GMP lab infrastructures, the robust patient programs of the Internal Medicine II and our well-established GCP Study Center (currently >60 active clinical trials and 300 patients/year) will provide substantial support to establish this translational research program.To enable the translational research part of the program, following two Major Research Instruments are mandatory and thus applied for in this application:(1) an instrument for GMP-compliant production of cell therapies for application in patient in clinical trials, with an additional electroporator in closed system (e.g., allogeneic NK cells, iNKT cells, CAR-T cells) and(2) a flow cytometer for the analysis of the produced cellular products and the monitoring of the immune cells and their effect on the immune system (immunomonitoring) as well as on the tumor cells in vivo (e.g., including quantification of the minimal residual disease).Within the next years, both Major Research Instrument will be used to generate cellular products and to perform the accompanying research for example for the following clinical trials:1. „A phase I/II dose finding and efficacy study of MB-CART-BCMA/CD19 in patients with advanced multiple myeloma“ (single-center, single-arm, phase I/II study, financial support awarded by the Medical Faculty Tübingen (AKF program), ; PI: B. Besemer/ Co-PI W. Bethge).2. “A phase I/II dose finding and efficacy study of MB-CART-CD19/CD22 in patients with advanced lymphoid malignancies” (single-center, single-arm, phase I/II study, financial support applied for at the Medical Faculty Tübingen (AKF program), PI: W. Bethge/ Co-PI C. Lengerke).3. „Natural Killer Cell Immunotherapy in combination with PARP-inhibition to overcome NKG2D-mediated immune evasion in Acute Myeloid Leukemia“ (NAKIP-AML; triple-center phase I/II study, PI Tübingen: Claudia Lengerke; Tübingen und Dresden: manufacturing centers for allogeneic NK cells; the study is based on pre-clinical data generated in the research group of Prof. Lengerke, see Paczulla,..., Lengerke. Nature, 2019; study has been awarded funding by the NCT)4. Similar as in (3) for consolidation after allogeneic transplantation at high risk AML (study in preparation, PI: C. Lengerke/ Co-PI: D. Schneidawind)5. iNKT cells and additional cellular therapies concerning graft-versus-host disease and other immunological diseases (study protocol in preparation, PI: D. Schneidawind/Co-PI: R. Haraszti)