Implementation of CAR T cells in a hospital pharmacy department

Tristan Castellino , Pauline Doucey, Ludovic Fouillet, Fabien Forges, Agnès Mace, Sandrine Menguy, Sophie Kalfon, Xavier Simoens. Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, France.

Background and Aim
Chimeric Antigen Receptor T cells (CAR-T cells) are Advanced Therapy Medicinal Products (ATMP) and are more specifically considered as Gene Therapy Medicinal Products (GTMP). CAR-T cells had demonstrated high response rates in patients with hematologic malignancies. They are genetically modified organisms (GMO) and their use must be authorized by the French Haut Conseil des Biotechnologies (HCB). Currently, marketed CAR-T cells are classified as Class 1 GMO by HCB and therefore need strict requirements and specific authorization for their use. In order to facilitate patients’ access to these innovative drugs, our establishment wished to develop this activity (1 million inhabitants). This work presents the building of the preliminary file required for the submission of the pharmaceutical project to the French Health Authorities.

Method
An a priori risk assessment was achieved with quality tools: the Failure Modes, Effects and Criticality Analysis (FMECA) and the Ishikawa diagram. A literature review was carried out about regulation and recommendation of the learned societies. Feedbacks from CAR-T cells user centers were collected. A multidisciplinary steering committee was also created to develop the project.

Results
A process mapping was used to precisely describe the CAR-T cells circuit. The risks and the criticality related to the GTMP were identified and the redaction of standard operating procedures could be anticipated. Since the current premises of the pharmacy department did not allow the manipulation of CAR-T cells, the construction of a cryopreservation room and a controlled atmosphere zone (CAA) in low pressure with “forward march” was decided. This configuration must guarantee the GMO containment up to Class 2 and the risk control for each stage of CAR-T cells circuit. The pharmaceutical, medical and technical staff will be trained and empowered to the handling of CAR-T cells. A Gantt chart was used to plan all stages of the project. Agreements with other hospitals have been drawn up in order to facilitate care coordination and to obtain specific authorizations.

Conclusion
To anticipate the public health challenges posed by these innovative therapies, our hospital pharmacy department has prepared to obtain the necessary authorizations. This work will be part of the territory shared medical project and will require a real multidisciplinary coordination. It represents a challenge for both medical and pharmaceutical teams in order to offer optimal care to patients suffering from hematologic malignancies.

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