A robust regulatory roadmap is crafted for both the CGT proof-of-concept platform and the modular CAR-T procedure. Early engagement with Notified Bodies and competent authorities ensures that device classification, pre-clinical testing, and evolving regulations are addressed in real time. A detailed European regulatory landscape analysis across EU countries (starting with Germany, Spain) informs consultation with TÜV, PEI, EMA, and other agencies, while comprehensive GMP documentation - including validation plans, risk assessments, and supplier qualification - lays the groundwork for compliant manufacturing in WP6.
Simulated onboarding workflows in hospital settings serve to pilot the point-of-care CAR-T platform, while also generating SOPs, training materials, and quality-management documents to assess personnel, infrastructure, and documentation requirements. Guided by insights from WP2 and WP3, this WP then conducts dry runs across partner sites, gathering usability feedback to iteratively refine device deployment and clinical processes while preparing for a clinical trial. Finally, interoperability tests validate data interfaces between the device, digital twin, and hospital IT systems, and a clinical study protocol is drafted alongside a comprehensive final report outlining logistics, user insights, and regulatory considerations.
Refining and validating the consumable cassette and core instrument to meet GMP specifications for on-site CAR-T production is performed in this working package: partners will iterate on the Point-of-Care (PoC) - cell and gene therapy cassette design (affinity capture, washing, concentration) and verify cell-isolation performance (purity, viability, yield) across multiple donor samples. Standardized quality-control cartridges and protocols will be developed to automate cell counts, viability checks, and contamination assays, by stakeholder feedback from WP8. Finally, a Digital Twin will integrate process and quality control data into hospital EHR/LIMS systems, enabling real-time interoperability and streamlined clinical workflows.
To ensure full compliance with applicable laws, regulations, and best practices, this working package defines an ethical framework and oversight structure guiding all research and device development activities. An ethics committee will be convened to review protocols, informed-consent materials, data-protection measures (e.g., GDPR compliance), and patient-safety procedures, providing guidance and approval at key milestones. Continuous monitoring and reporting mechanisms will be implemented to address any emerging ethical issues throughout the project lifecycle.
Bertram is the Chief Physician of Hematology and Cell Therapy and the Director of the Hematology and Stem Cell Transplantation Center at Helios Klinikum Berlin-Buch. His specialization includes malignant lymphomas, acute leukemia, and cell therapy, particularly CAR-T therapies. He is an active member of the German Lymphoma Alliance and serves as the speaker of the aggressive lymphoma subcommittee of EBMT. Bertram has dedicated his career to clinical research and the application of cutting-edge treatments in hematology and immunotherapy.
Emin is a board-certified specialist in internal medicine, hematology, and oncology at Helios Klinikum Berlin-Buch, based in Schwanebecker Chaussee, Berlin. He provides both inpatient and outpatient care through the hospital’s internal medicine and hematology – cell therapy clinic. With expertise in the diagnosis and management of complex hematologic and oncologic conditions, he delivers comprehensive patient care and collaborates across interdisciplinary tumor boards and treatment teams.
Johanna is a board-certified oncologist (Fachärztin für Onkologie) serving as an attending physician at Helios Klinikum Berlin-Buch’s Hematology/Oncology department. She provides expert cancer diagnosis and treatment in both inpatient and outpatient settings and collaborates closely within interdisciplinary tumor boards. Johanna is recognized for her commitment to patient-centered, evidence-based oncology care at a major academic medical center in Berlin.
Lisa is Senior Physician and Quality Management Lead in Internal Medicine at Helios Clinic Berlin-Buch. A specialist in internal medicine with an additional qualification in palliative care, she is completing her sub-specialization in hemato-oncology and has experience in treating malignant lymphomas and administering advanced cell therapies, including CAR-T approaches. Passionate about integrating clinical care with innovative therapies, Lisa drives quality initiatives and multidisciplinary collaboration within the hematology and stem cell transplantation unit.
Anna is a Board-Certified Physician in training at Helios Klinikum Berlin-Buch, where she serves as Assistant Resident in Hematology and Cell Therapy and heads the Clinical Trials Office. She specializes in malignant lymphomas and immunotherapy, notably pioneering CAR-T cell treatment for patients with central nervous system (CNS) lymphoma — an area traditionally excluded from trials. Her retrospective study, demonstrating comparable efficacy and safety in CNS lymphoma cases, earned first prize at the 2024 Helios Clinical Congress and is shaping new treatment standards.
