Project Details
Projekt
Platform for the automatic production of cellular products
Subject Area
Medicine
Term
Funded in 2021
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 467577550
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 with an additional electroporator for the GMP-compliant production of cellular components for therapies (e.g., allogeneic NK cells, iNKT cells, CAR-T cells), used for the application in clinical studies 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 Instruments 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).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).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)4. Similar as in (3) for consolidation after allogeneic transplantation at high risk AML (study in preparation)5. iNKT cells and additional cellular therapies concerning graft-versus-host disease and other immunological diseases (study protocol in preparation)
DFG Programme
Major Research Instrumentation
Major Instrumentation
Plattform zur automatisierten Herstellung von Zellprodukten
Instrumentation Group
1220 Spezielle Zentrifugen (Verfahrenstechnik, Medizin)
Applicant Institution
Eberhard Karls Universität Tübingen
