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T2EVOLVE: STANDARDIZATION OF PRE-CLINICAL AND CLINICAL DEVELOPMENT OF ENGINEERED T CELL THERAPY IN EUROPE; A CROSS FUNCTIONAL MULTI STAKEHOLDER INITIATIVE
T2EVOLVE is a breakthrough alliance of academic and industry leaders in cancer immunotherapy that started in 2021, under the European Union's Innovative Medicines Initiative (IMI). The key objective of T2EVOLVE is to accelerate the development of engineered T-cell therapies and increase their a...
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Published in: | Cytotherapy (Oxford, England) England), 2024-06, Vol.26 (6), p.S117-S118 |
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Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Online Access: | Get full text |
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Summary: | T2EVOLVE is a breakthrough alliance of academic and industry leaders in cancer immunotherapy that started in 2021, under the European Union's Innovative Medicines Initiative (IMI). The key objective of T2EVOLVE is to accelerate the development of engineered T-cell therapies and increase their access for patients by providing guidance, standards and novel models for the advancement of engineered T cells on the research, regulatory and educational level.
T2EVOLVE has thoroughly screened the current preclinical models that assess the safety and effectiveness of engineered T-cell therapies and identified specific unmet needs and gaps that must be addressed to move forward. Key opinion leaders are developing ex vivo models, standardizing procedures and approaching regulators to bridge these gaps and advance the research.
Through our engagement with patient associations, patients and caregivers, healthcare professionals and other relevant stakeholders, we have successfully developed and launched the European patient survey on CAR T-cell therapy. This online survey was aimed at understanding the experiences of patients, evaluating the impact of this treatment on their quality of life and identifying any unmet needs they may have. Moreover, topics for new explainer videos were identified and prioritized. T2EVOLVE organized a workshop with regulatory authorities to discuss the parent-child approach in Europe.
Seven new preclinical models are currently being tested across the consortium partners. The Patient survey results are expected in the next upcoming month, counting on almost 400 participants' feedback. The first explainer video, How to look for reliable information on the internet, developed with the collaboration of patients and caregivers, is going to be launched soon. The parent-child workshop has served as inspiration for a white paper that was just recently published along with an overview about current lymphodepletion strategies and their future directions.
T2EVOLVE is developing new tools and standards that consortium partners will validate to provide investigators and clinicians with innovative assays and guidelines for improved pre-clinical development, immunomonitoring, and GMP manufacturing. Moreover, patient involvement will ensure that cancer patients' perspectives are listened to and incorporated, reflected in educational materials and the research setting. |
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ISSN: | 1465-3249 1477-2566 |
DOI: | 10.1016/j.jcyt.2024.03.223 |