Tisagenlecleucel

Mechanism of action

T cells collected from the patient by leukapheresis are given a chimeric antigen receptor: a mouse single-chain antibody fragment that recognises CD19, joined to the signalling domains of 4-1BB (CD137) and CD3ζ. CD3ζ starts T-cell activation and 4-1BB supports expansion and survival. After lymphodepleting chemotherapy the cells are infused once; they recognise CD19 without MHC, kill the B cells and multiply, releasing cytokines.

1. The patient's T cells are collected and given an anti-CD19 CAR
2. Lymphodepleting chemotherapy, then a single infusion
3. CAR T cells bind CD19 and kill B cells
4. Expansion releases cytokines (CRS risk)

Indications

• B-cell acute lymphoblastic leukaemia in patients up to 25 years of age that is refractory or in second or later relapse. Acute leukaemia (AML and ALL) →
• Relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma) and follicular lymphoma after at least two lines of systemic therapy. Non-Hodgkin lymphoma →

Adverse effects

Common

• Fever and other signs of cytokine release
• Low blood counts
• Infections
• Decreased appetite, nausea, diarrhoea or constipation
• Fatigue, headache

Contraindications

• Known allergy to components of the product
• Active uncontrolled infection is treated before infusion

Key interactions

Corticosteroids (e.g. dexamethasone, methylprednisolone, prednisone)

Avoided for other reasons around infusion unless needed, because they suppress T cells; they are used on purpose to treat severe CRS or neurotoxicity.

Live vaccines

Not given before lymphodepletion, during treatment or until immune recovery.

Tocilizumab

Not an interaction to avoid: it is the treatment for severe cytokine release syndrome and is kept available before the infusion.

What is monitored

• Temperature, blood pressure, heart rate and oxygen saturation frequently in the first weeks
• Neurological checks (orientation, speech, handwriting)
• Complete blood count and signs of infection
• History of hepatitis B, hepatitis C and HIV checked before cell collection
• Long-term follow-up for new cancers

Administration and safety

• Given only at certified treatment centres within the FDA risk management programme (REMS).
• The bag is for this patient only: identity is checked against the bag label before infusion.
• Thawed and infused intravenously as a single dose; premedication is given as ordered.
• Tocilizumab and emergency equipment are available before the infusion starts.

Pregnancy and breastfeeding

May harm the fetus; a pregnancy test is done before treatment.

Nursing care

• Check vital signs often; report fever, hypotension or low oxygen saturation at once (cytokine release syndrome).
• Do neurological checks every shift and report confusion, word-finding difficulty or tremor.
• Watch for infection and bleeding.
• Teaching: stay within about two hours of the centre for at least four weeks, do not drive for at least eight weeks, do not donate blood, organs or cells, and tell testers about the treatment (false-positive HIV tests).

Pharmacokinetics

Distribution

The infused cells expand in the blood and travel to bone marrow and other tissues.

Elimination

A living product: the cells can persist for a long time.

Test yourself

Think of the answer, then tap the question to see it.

Add to my cards (4)

More Pharmacology questions →

Connections

← Back to the class: CAR T-cell therapies

Educational content on how drugs work; not a prescribing guide and no substitute for a health professional's advice. No doses are given.

Sources: Tisagenlecleucel Injection: MedlinePlus Drug Information (MedlinePlus (U.S. National Library of Medicine), 2026); Tisagenlecleucel - NCI (National Cancer Institute, 2026); ATCDDD - ATC/DDD Index (WHO Collaborating Centre for Drug Statistics Methodology, 2026).

Spotted a mistake?We are always improving for the community. Tell us what is wrong and our team will review it.Report a mistake

Send

Representative model, for educational purposes only.