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How it is administered
Axicabtagene ciloleucel is administered as a single intravenous (IV) infusion. The medication is prepared individually for each patient using their own T cells, which are collected through a process called leukapheresis. These T cells are then genetically modified and expanded in a laboratory before being returned to the patient as a frozen suspension in a patient-specific infusion bag. The product is thawed before infusion and given through a central venous line.
Before receiving axicabtagene ciloleucel, patients are given a short course of chemotherapy (lymphodepleting regimen) with cyclophosphamide and fludarabine to prepare their body for the treatment. Patients are also premedicated with acetaminophen and an antihistamine to help prevent infusion reactions.
How it works
Axicabtagene ciloleucel is a type of immunotherapy known as CAR T-cell therapy. It works by using your own immune cells (T cells) that have been genetically modified to recognize and attack cancer cells. The T cells are engineered to express a special receptor called a chimeric antigen receptor (CAR) that targets the CD19 protein found on the surface of B cells, including those that are cancerous in large B-cell lymphoma.
When these modified T cells are infused back into your body, they seek out and bind to CD19-expressing cells. This binding activates the T cells, causing them to multiply and release substances that kill the cancer cells. This process can lead to a rapid and powerful immune response against the lymphoma. However, it can also affect normal B cells, leading to a temporary reduction in healthy B cells (B-cell aplasia).
Common side effects
- Cytokine Release Syndrome (CRS) (fever, chills, low blood pressure, rapid heartbeat, difficulty breathing)
- Neurologic toxicities (confusion, headache, tremor, dizziness, difficulty speaking, seizures)
- Fever
- Fatigue
- Hypotension (low blood pressure)
- Encephalopathy (altered mental state)
- Tachycardia (fast heartbeat)
- Headache
- Nausea
- Febrile neutropenia (fever with low white blood cell count)
- Diarrhea
- Musculoskeletal pain
- Infections
- Chills
- Decreased appetite
Common laboratory abnormalities include low white blood cells, low neutrophils, low lymphocytes, anemia, low platelets, and low phosphate.
Who Should take it
Axicabtagene ciloleucel is indicated for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. It is also approved for adults with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
This therapy is considered for patients whose disease has not responded to standard treatments or has come back after initial treatments. It is not used as a first-line therapy but is an option for those with difficult-to-treat or aggressive forms of B-cell lymphoma.
Who should not take it
There are no absolute contraindications listed for axicabtagene ciloleucel. However, it should not be used in patients with clinically significant active systemic infections, including those with hepatitis B, hepatitis C, or HIV, unless these conditions are well controlled. Patients with active central nervous system lymphoma or those who are not candidates for intensive therapy due to poor overall health may not be suitable for this treatment.
Pregnant women should not receive axicabtagene ciloleucel, as its effects on pregnancy are unknown and it may harm the fetus. The safety and efficacy of this therapy have not been established in pediatric patients. Patients should discuss their full medical history with their healthcare team to determine if this therapy is appropriate for them.
Commonly used with
Axicabtagene ciloleucel is typically used as a single-agent therapy, but it is given after a preparatory (lymphodepleting) chemotherapy regimen with cyclophosphamide and fludarabine. Patients are also premedicated with acetaminophen and an antihistamine to help prevent infusion reactions.
During treatment, supportive medications such as tocilizumab (for cytokine release syndrome) and corticosteroids (for severe side effects) may be used if needed.
Commonly tested with
In clinical trials, axicabtagene ciloleucel has been tested in combination with lymphodepleting chemotherapy agents such as cyclophosphamide and fludarabine. Supportive medications like tocilizumab and corticosteroids are also commonly used in the management of side effects during clinical studies.
Patients in studies are closely monitored with regular blood tests and clinical assessments to track response and manage potential side effects.
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