Selection of potential target antigens & effective CAR/TZR constructs; high regulatory effort in the development and clinical implementation of such advanced therapy medicinal products (ATMPs); GMP production of ATMPs; characterization of the mode of action in patients; overcoming primary and secondary therapy resistance; prevention and monitoring of novel side effects.
Added value: Combining the extensive previous experience and expertise of the Bavarian university hospitals in this field of research; division of tasks based on existing strengths, cross-location development and utilization concept.
Division of labor through modules:
Preclinical development (Würzburg University Hospital)
- Strategic planning for translation and development
- Carrying out the necessary assays
- Data preparation and presentation for authorities
Regulatory affairs (Clinical Center TU Munich)
- Establishment of a regulatory group
- Networking and exchange with regulatory authorities, politics, the Bavarian Patent Alliance and patient interest groups
- Exchange with biotech companies
GMP production of cell therapeutics (University Hospital Erlangen)
- Consulting, establishment and validation of manufacturing methods and quality control methods for ATMPs
- Applying for and obtaining manufacturing authorization
Toxicity management (LMU Munich Hospital)
- Interdisciplinary BZKF research network for cell therapy toxicities
- Central data collection of cell therapy toxicities
- App-based publication of current therapy recommendations for toxicity management
Immunomonitoring (University Hospital Regensburg)
- Acceptance, coding, pseudonymization and storage of biosamples
- Advice, sample analysis, sample evaluation
- Data storage & transfer
Preclinical development
- Innovation pipeline: Selection and refinement of two CAR/TZR constructs for joint clinical trials
- IND package and further development of clinical studies
Regulatory
- Establishment of a quick reference guide with PEI and regulatory hub
- Catalyzing a joint ATMP development
GMP manufacturing of cell therapeutics
- Exchange of documents and implementation of consultations/trainings
- Joint audits and development of joint SOPs
- Joint argumentation strategy for common problems
Toxicity management
- Availability of an eCRF platform for centralized data collection of cell therapy toxicities
- Shared data collection / SOPs for different CAR/TZRs
- Patient advocacy program for the implementation of the patient perspective in future CAR/TZR studies
Immunomonitoring
- Cross-site advanced immunomonitoring for commercial CD19-CART products.
- Expansion of the method portfolio for liquid samples
- Establishment of procedures for the analysis of (fresh and frozen) solid tumor tissue
- Establishment of a unique lighthouse in Germany with comparable effectiveness and impact to the immunotherapy hubs of the major US centers
- Completed functional lighthouse by 01.07.2024
- Coordination of CAR/TZR study concepts with the entity-specific study groups of the BZKF
- Implementation of cross-site studies with CAR/TZR gene-modified T cells in advanced tumor diseases
Speaker: Prof. Wolfgang Herr(Wolfgang.Herr@klinik.uni-regensburg.de, 0941 944-5501 ), University Hospital Regensburg
