ciltacabtagene autoleucel: clinical use

Prescribing considerations

• Administer only at a qualified treatment centre with trained staff, emergency equipment and immediate access to appropriate cytokine release syndrome treatment.
• Confirm product availability and patient-specific identity before preparatory treatment and infusion.
• Assess disease tempo because rapid progression during manufacture or bridging therapy may prevent safe receipt of CAR T cells.
• Delay infusion for clinically significant active infection or inflammation, unresolved severe non-haematological toxicity from preparatory therapy, or active graft-versus-host disease.
• Use particular caution with significant current or previous CNS disease or inadequate cardiac, pulmonary, hepatic or renal function.
• Arrange long-term follow-up and lifelong surveillance for secondary malignancy.

Contraindications and cautions

• Hypersensitivity to ciltacabtagene autoleucel or an excipient.
• Contraindications to preparatory chemotherapy or supportive treatments must also be considered.
• The patient-specific product must never be given to another person.

Monitoring

• Screen for HIV, hepatitis B, hepatitis C and other relevant infections before cell collection.
• Assess blood counts, organ function, infection status and neurological baseline before infusion.
• Monitor for cytokine release syndrome, ICANS and other toxicities, including delayed movement, cognitive, cranial-nerve and peripheral neurological syndromes.
• Monitor blood counts, immunoglobulins and infection risk; manage prolonged cytopenias and hypogammaglobulinaemia appropriately.
• Monitor for immune-mediated enterocolitis and secondary myeloid or T-cell malignancies.
• The lentiviral vector may cause false-positive results with some HIV nucleic-acid tests.

Clinical pharmacology

Autologous T cells are genetically modified using a lentiviral vector to express a CAR containing two BCMA-targeting domains. BCMA binding triggers CAR T-cell activation, expansion, cytokine release and cytotoxic killing of BCMA-expressing cells.

Formulation and product differences

• A patient-specific, cryopreserved dispersion for intravenous infusion supplied in an infusion bag.
• Cell concentration, total cell content and volume vary between patient batches and are documented on the lot information sheet.
• Contains dimethyl sulfoxide and may contain residual kanamycin, which can contribute to hypersensitivity reactions.
• The thawed product must not be refrozen, refrigerated, shaken or passed through a leukodepleting filter.