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Prérequis nécessaires pour la mise en place de protocoles de recherche clinique évaluant des thérapies cellulaires et géniques par lymphocytes T dotés de récepteur chimérique à l’antigène (CAR T-cells) : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC)
- Source :
- Bulletin du Cancer, Bulletin du Cancer, John Libbey Eurotext, 2017, 104 (12), pp.S43-S58. ⟨10.1016/j.bulcan.2017.10.017⟩, Bulletin du Cancer, 2017, 104 (12), pp.S43-S58. ⟨10.1016/j.bulcan.2017.10.017⟩
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- CAR T-cells are autologous or allogeneic human lymphocytes that are genetically engineered to express a chimeric antigen receptor targeting an antigen expressed on tumor cells such as CD19. CAR T-cells represent a new class of medicinal products, and belong to the broad category of Advanced Therapy Medicinal Products (ATMPs), as defined by EC Regulation 2007-1394. Specifically, they are categorized as gene therapy medicinal products. Although CAR T-cells are cellular therapies, the organization for manufacturing and delivery is far different from the one used to deliver hematopoietic cell grafts, for different reasons including their classification as medicinal products. Currently available clinical observations were mostly produced in the context of trials conducted either in the USA or in China. They demonstrate remarkable efficacy for patients presenting advanced or poor-prognosis hematological malignancies, however with severe side effects in a significant proportion of patients. Toxicities can and must be anticipated and dealt with in the context of a full coordination between the clinical cell therapy ward in charge of the patient, and the neighboring intensive care unit. The present workshop aimed at identifying prerequisites to be met in order for French hospitals to get efficiently organized and fulfill sponsors' expectations before initiation of clinical trials designed to investigate CAR T-cells.
- Subjects :
- 0301 basic medicine
Cancer Research
Genetic enhancement
medicine.medical_treatment
Context (language use)
Hematopoietic stem cell transplantation
Bioinformatics
Cell therapy
03 medical and health sciences
0302 clinical medicine
Antigen
medicine
Radiology, Nuclear Medicine and imaging
ComputingMilieux_MISCELLANEOUS
business.industry
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
Hematology
General Medicine
Chimeric antigen receptor
3. Good health
Clinical trial
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
Chimeric Antigen Receptor T-Cell Therapy
business
Subjects
Details
- ISSN :
- 00074551 and 17696917
- Volume :
- 104
- Database :
- OpenAIRE
- Journal :
- Bulletin du Cancer
- Accession number :
- edsair.doi.dedup.....19ec39af8d04c92821ec6880be70b425