[Durgical](https://durgical.com/en/) › [DurgiPedia](https://durgical.com/en/durgipedia/) › [Pharmacology](https://durgical.com/en/pharmacology/) › [CAR T-cell therapies](https://durgical.com/en/pharmacology/classes/car-t-cell-therapies/) › Tisagenlecleucel

# Tisagenlecleucel

## CAR T-cell therapies?

CAR T-cell therapies

## High alert?

An error with this medicine can cause serious harm: double checks and protocols are used.

The first CD19 CAR T-cell therapy: the patient's own T cells, engineered to kill B-cell leukaemia and lymphoma. Main risks: cytokine release and neurotoxicity.

Updated Nov 1, 2026

Also called: CTL019, CD19 CAR T cells

## Quick facts

**Group**
[CAR T-cell therapies](https://durgical.com/en/pharmacology/classes/car-t-cell-therapies/)

**Target**
CD19 on normal and malignant B cells

**Used for**
B-cell acute lymphoblastic leukaemia

**Key effects**
Fever and other signs · Low blood counts · Infections

**Monitor**
Temperature · Neurological checks

**ATC**
L01XL04

No doses: the clinician sets them by the current guideline.

On this page

- The basics Mechanism of action
- Indications
- Adverse effects
- Pharmacokinetics
- Memory aid

- Clinical What the labels mean

- Safety Contraindications
- Key interactions
- What is monitored
- Administration and safety
- Pregnancy and breastfeeding
- Nursing care

- Study Test yourself

- Connections Connections

## 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.

- The patient's T cells are collected and given an anti-CD19 CAR
- Lymphodepleting chemotherapy, then a single infusion
- CAR T cells bind CD19 and kill B cells
- 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) →](https://durgical.com/en/conditions/acute-leukaemia/)
- 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 →](https://durgical.com/en/conditions/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

### Serious (rare, important)

- Cytokine release syndrome: high fever, hypotension, hypoxia, organ dysfunction (boxed warning)
- Neurological toxicity: confusion, seizures, speech or balance problems (boxed warning)
- Secondary T-cell malignancies, including CAR-positive lymphoma (boxed warning)
- Serious infections and low blood counts with bleeding
- Hypersensitivity reactions

## 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.

## Memory aid

«tisa-GEN-LEU-CEL» = GENetically modified LEUkocytes as a CELL drug; its two alarms are «Fever and Fog» (CRS and neurotoxicity).

## Test yourself

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

## What does tisagenlecleucel recognise?

CD19 on normal and malignant B cells.

## Which two intracellular domains does the tisagenlecleucel CAR contain?

4-1BB (CD137) and CD3ζ.

## Which drug is kept ready to treat severe cytokine release syndrome?

Tocilizumab, an antibody against the IL-6 receptor.

## Why must patients stay close to the treatment centre after the infusion?

Because cytokine release syndrome and neurotoxicity can start days to weeks later and need urgent care.

[Add to my cards (4)](https://durgical.app/estudiar/?add=/en/pharmacology/tisagenlecleucel/)

[More Pharmacology questions →](https://durgical.com/en/practice/?f=pharmacology)

## What the labels mean

**High alert**
An error with this medicine can cause serious harm: double checks and protocols are used.

## Connections

## Related drugs 3

- [Axicabtagene ciloleucel](https://durgical.com/en/pharmacology/axicabtagene-ciloleucel/)
- [Tocilizumab](https://durgical.com/en/pharmacology/tocilizumab/)
- [Blinatumomab](https://durgical.com/en/pharmacology/blinatumomab/)

## Related conditions 2

- [Acute leukaemia (AML and ALL)](https://durgical.com/en/conditions/acute-leukaemia/)
- [Non-Hodgkin lymphoma](https://durgical.com/en/conditions/non-hodgkin-lymphoma/)

[← Back to the class: CAR T-cell therapies](https://durgical.com/en/pharmacology/classes/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](https://medlineplus.gov/druginfo/meds/a617053.html) (MedlinePlus (U.S. National Library of Medicine), 2026); [Tisagenlecleucel - NCI](https://www.cancer.gov/about-cancer/treatment/drugs/tisagenlecleucel) (National Cancer Institute, 2026); [ATCDDD - ATC/DDD Index](https://atcddd.fhi.no/atc_ddd_index/?code=L01XL04) (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

Representative model, for educational purposes only.

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Source: https://durgical.com/en/pharmacology/tisagenlecleucel/
License: CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). Cite as: DurgiPedia (durgical.com), https://durgical.com/en/pharmacology/tisagenlecleucel/