tisagenlecleucel at a glance
Medicine class
Autologous CD19-directed CAR T-cell therapy and advanced therapy medicinal product
Main uses
Selected relapsed or refractory B-cell acute lymphoblastic leukaemia, diffuse large B-cell lymphoma and follicular lymphoma
Administration
Intravenous infusion in a qualified specialist treatment centre
Personalised product
Made from the individual patient’s collected white blood cells and must not be given to anyone else
After treatment
Close monitoring is required; remain within two hours’ travel of a qualified clinical facility for at least four weeks
What is tisagenlecleucel used for?
UK-licensed uses represented by the selected product are:
B-cell acute lymphoblastic leukaemia in children and young adults up to and including 25 years when refractory, relapsing after transplant, or in second or later relapse.
Relapsed or refractory diffuse large B-cell lymphoma in adults after at least two previous lines of systemic therapy.
Relapsed or refractory follicular lymphoma in adults after at least two previous lines of systemic therapy.
How does tisagenlecleucel work?
The patient’s T cells are modified to carry a chimeric antigen receptor that recognises CD19 on targeted B cells. Binding activates the modified cells, supporting their expansion and destruction of CD19-expressing cells.
How to take tisagenlecleucel
Tisagenlecleucel is not taken at home. White blood cells are collected by leukapheresis and sent for manufacture. The finished patient-specific cell dispersion is given intravenously by a trained team in a qualified centre.
The team checks that the patient identifiers on the infusion bag and documents match the recipient.
Preparatory chemotherapy may be required before infusion.
Paracetamol and an antihistamine may be given beforehand to reduce infusion reactions.
Stay close to the treatment centre and attend all planned monitoring appointments.
Do not donate blood, organs, tissues or cells after treatment.
tisagenlecleucel side effects
Common or expected effects
- Fever, fatigue, headache, reduced appetite, nausea, vomiting, diarrhoea or abdominal discomfort
- Infections or reduced antibody levels
- Low red cells, white cells or platelets, potentially causing tiredness, infection, bruising or bleeding
- Cough, breathlessness, low oxygen levels or blood-pressure changes
- Muscle, joint or other pain, swelling and rash
- Cytokine release syndrome and neurological effects, which may be serious
Get urgent medical advice
- Cytokine release syndrome
- Neurotoxicity or ICANS
- Serious infection
- Severe or prolonged low blood counts, bleeding or bruising
- Anaphylaxis or another severe infusion reaction
- Tumour lysis syndrome or organ dysfunction
- A rare secondary malignancy arising from T cells has been reported after CAR T-cell therapies
tisagenlecleucel in pregnancy
There are no adequate pregnancy data, and possible fetal harm—including B-cell depletion—cannot be excluded. Tisagenlecleucel is not recommended during pregnancy. Pregnancy status should be checked beforehand, and pregnancy or pregnancy planning after treatment should be discussed with the specialist team. Immunoglobulin levels should be assessed in a newborn whose mother received tisagenlecleucel.
tisagenlecleucel while breastfeeding
It is unknown whether tisagenlecleucel cells enter breast milk, and risk to a breastfed child cannot be excluded. Breastfeeding after treatment requires individual discussion with the treating specialist.
tisagenlecleucel interactions
Formal interaction studies are limited. The specialist team should review all prescribed, over-the-counter and complementary products.
Live vaccines
Avoid around treatment and until immune recovery because safety has not been established and immune suppression may increase risk.
Medicines that suppress T-cell function, including systemic corticosteroids
They may interfere with CAR T-cell activity. Corticosteroid use should be directed by the specialist team, including when required for serious toxicity.
Medicines that stimulate T-cell function
Concurrent use has not been studied, so the effects are unknown.
Common questions about tisagenlecleucel
Answers are fully visible for fast scanning and source review.
What is tisagenlecleucel made from?
The patient’s own T cells, collected and genetically modified to recognise CD19 on targeted B cells.
Can another person receive my cells?
No. The product is made for one named patient and must not be given to anyone else.
Can tisagenlecleucel affect the nervous system?
Yes. It can cause ICANS or other neurological effects, including confusion, altered consciousness, seizures, speech difficulty or problems walking.
Can I drive after treatment?
Avoid driving, operating machinery and other activities requiring full alertness for eight weeks because neurological effects can impair consciousness or coordination.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.