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ciltacabtagene autoleucel (Carvykti)
CAR-T Cell Therapy
Administration: iv

How it is administered

Ciltacabtagene autoleucel is administered as a single intravenous (IV) infusion. It is an autologous cell therapy, meaning it is made from your own T cells, which are collected through a process called leukapheresis. After collection, your T cells are genetically modified in a laboratory to target a protein called BCMA found on multiple myeloma cells. The modified cells are then expanded, frozen, and shipped back to your treatment center, where they are thawed and infused back into your bloodstream.

Before the infusion, you will receive a short course of chemotherapy (lymphodepleting regimen) to prepare your body for the treatment. The entire process, from cell collection to infusion, can take several weeks.

How it works

Ciltacabtagene autoleucel is a type of CAR-T cell therapy specifically designed to treat multiple myeloma. It works by reprogramming your own T cells to recognize and attack cancer cells that express the B-cell maturation antigen (BCMA), a protein commonly found on the surface of multiple myeloma cells.

Once infused back into your body, these engineered T cells seek out and bind to BCMA on the cancer cells. This binding activates the T cells, causing them to multiply and release substances that kill the cancer cells. The therapy can lead to a rapid and significant reduction in the number of myeloma cells, and in many cases, a deep and lasting remission. However, because the therapy also activates the immune system, it can cause significant side effects that require close monitoring.

Common side effects

  • Pyrexia (fever)
  • Cytokine release syndrome (CRS)
  • Hypogammaglobulinemia (low antibody levels)
  • Hypotension (low blood pressure)
  • Musculoskeletal pain
  • Fatigue
  • Infections (unspecified pathogen, viral, bacterial, fungal)
  • Cough
  • Chills
  • Diarrhea
  • Nausea
  • Encephalopathy (brain dysfunction)
  • Decreased appetite
  • Upper respiratory tract infection
  • Headache
  • Tachycardia (fast heartbeat)
  • Dizziness
  • Dyspnea (shortness of breath)
  • Edema (swelling)
  • Coagulopathy (blood clotting problems)
  • Constipation
  • Vomiting

Serious side effects can include severe infections, prolonged low blood counts, neurologic toxicities (such as confusion, seizures, or movement disorders), and secondary cancers. Close monitoring is required after infusion.

Who Should take it

Ciltacabtagene autoleucel is indicated for adult patients with relapsed or refractory multiple myeloma. Specifically, it is for those who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose disease is refractory to lenalidomide.

This therapy is typically considered when other standard treatments have not worked or the disease has returned after initial treatment. Your healthcare team will determine if you are a suitable candidate based on your treatment history, overall health, and specific characteristics of your multiple myeloma.

Who should not take it

There are no absolute contraindications listed for ciltacabtagene autoleucel. However, it should not be given to patients with active infections or inflammatory disorders at the time of planned infusion.

The safety and effectiveness of this therapy have not been established in children or in patients with certain health conditions, such as significant central nervous system disease, or those who are pregnant. Women who are pregnant or of childbearing potential not using contraception should avoid this therapy due to potential risks to the fetus. Your doctor will carefully assess your health status before recommending this treatment.

Commonly used with

Ciltacabtagene autoleucel is typically used as a single-agent therapy for multiple myeloma after other treatments have failed. However, before the infusion, patients receive a lymphodepleting chemotherapy regimen, usually with cyclophosphamide and fludarabine, to prepare the body for the CAR-T cells.

Supportive medications such as acetaminophen and antihistamines are given before the infusion to reduce the risk of infusion reactions. Medications like tocilizumab and corticosteroids may be used to manage side effects such as cytokine release syndrome or neurologic events.

Commonly tested with

In clinical trials, ciltacabtagene autoleucel has been tested in patients who have previously received a variety of multiple myeloma treatments, including proteasome inhibitors (like bortezomib), immunomodulatory drugs (like lenalidomide or pomalidomide), and anti-CD38 monoclonal antibodies (like daratumumab).

During the manufacturing process and before infusion, patients may receive 'bridging therapy' with other anti-myeloma drugs to control disease progression. The lymphodepleting chemotherapy regimen (cyclophosphamide and fludarabine) is always used immediately before CAR-T cell infusion.

Medication Videos

All About CARVYKTI
Cilta-Cel | Mark Wildgust, PhD | ASH 2021
What is car T cell therapy?
What are the side effects of CAR-T cell therapy?
Where can patients go to get CAR T therapy?
How do CAR T cells kill myeloma cells?
Who is eligible for CAR T therapy?
Treating multiple myeloma with cilta-cel.
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