Clinical management of patients at site

Includes exemplar SOPs and information regarding the clinical management of patients receiving advanced therapies in a hospital setting, covering patient consent, treatment, management of toxicities and follow-up care.


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All CAR-T follow up checklist

CAR-T follow up checklist
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Cytokine release syndrome assessment for CAR-T therapy – Newcastle Hospitals

A tool to assess for, and grade, cytokine release syndrome in a CAR T therapy patient
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Diagnosis and medical management of acute CAR-T cell toxicities in adults

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.
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Guidelines for management of Cytokine Release Syndrome

Policy and guidelines on the management of Cytokine Release Syndrome with cellular therapies (notably CAR-T cells) and bi-specific T cell engaging antibodies (eg blinatumomab).
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Management of GMO Spillage or Accidental Exposure in a Clinical Area – example SOP

This SOP considers general principles for the management of a Class 1 or 2 GMO gene therapy spillage or accidental exposure in a clinical area.
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Medical Assessment of patients for bone marrow harvest or therapeutic apheresis

Template proforma for medical assessment of patients for bone marrow harvest or therapeutic apheresis
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SOP – Shared Care for Adult CAR-T Patients

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust detailing effective shared care between the treatment centre and referring centre.
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SOP: CAR-T therapy discharge and follow up. CAR-T service pathway – post infusion

SOP for safe discharge and follow-up for patients, post Chimeric Antigen Receptor (CAR) T-cell therapy infusion.
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SOP: Handling and Administration of In vivo GMO Gene Therapies

This example SOP considers general principles for the handling and administration of an example in vivo GMO gene therapy in a clinical area which can be adapted to accommodate local procedures or product-specific requirements.
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SOP: Infusion of cellular products

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.
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SOP: Inpatient Management of Patients Receiving Immune Effector Cells (Including CAR-T Cells)

Outline guide for management of inpatients receiving immune effector cells
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SOP: Training for Pharmacists involved in Haematopoietic Cellular Therapies

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.