How it is administered

Tisagenlecleucel is given as a single intravenous (IV) infusion. The medication is made from your own T cells, which are collected through a process called leukapheresis. These cells are then modified in a lab to target cancer cells and returned to you as a personalized treatment. The dose is based on your weight and disease type, and it is provided in one to three infusion bags. Before receiving tisagenlecleucel, you may receive chemotherapy to prepare your body for the infusion.

How it works

Tisagenlecleucel is a type of CAR-T cell therapy. It works by taking some of your own T cells (a type of immune cell), modifying them in a laboratory to recognize and attack cancer cells that express a protein called CD19, and then infusing them back into your body. The modified T cells are equipped with a chimeric antigen receptor (CAR) that specifically binds to CD19, which is commonly found on the surface of B-cell cancers like large B-cell lymphoma.

Once infused, these CAR-T cells can find and destroy both cancerous and normal B cells that have CD19. This process can lead to a period where you have very few B cells (B-cell aplasia), which is expected and monitored by your healthcare team. The therapy is designed to help your immune system better recognize and fight the lymphoma.

Who Should take it

Tisagenlecleucel is indicated for adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) after two or more lines of systemic therapy. It is also approved for certain types of relapsed or refractory follicular lymphoma and for children and young adults up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL).

This treatment is generally considered when other standard treatments have not worked or the lymphoma has returned after previous therapies. Your healthcare team will determine if tisagenlecleucel is appropriate for you based on your specific diagnosis, previous treatments, and overall health.

Who should not take it

There are no absolute contraindications listed for tisagenlecleucel, but it should not be given to patients with active, uncontrolled infections or unresolved serious side effects from previous chemotherapy. It is not recommended for patients with primary central nervous system lymphoma or for women who are pregnant, as the effects on unborn babies are unknown and there is a potential risk of fetal toxicity.

Patients with active hepatitis B, hepatitis C, or HIV should be evaluated carefully before treatment, as there is limited experience in these populations. Your doctor will also screen for infections and other health issues before starting the process.

Commonly used with

Before receiving tisagenlecleucel, patients typically receive lymphodepleting chemotherapy, most often with fludarabine and cyclophosphamide, or sometimes bendamustine. These medications help prepare your body for the CAR-T cell infusion.

During or after treatment, supportive medications such as acetaminophen and antihistamines are used to help prevent infusion reactions. Tocilizumab and corticosteroids may be used to manage side effects like cytokine release syndrome.

Commonly tested with

Tisagenlecleucel has been studied in combination with lymphodepleting chemotherapy regimens (fludarabine and cyclophosphamide, or bendamustine) as part of the treatment protocol. In clinical trials, supportive care medications such as tocilizumab (for CRS) and corticosteroids were also used as needed to manage side effects.

No specific drug combinations are routinely tested with tisagenlecleucel outside of these supportive and preparatory therapies.